(Updated: 2026) New Cancer Drugs Insurance Denial

Lawyer to Help with New Cancer Drug Insurance Denials

Insurance companies seem to be denying claims for medical treatments or necessary prescribed drugs more and more often. This can be incredibly disheartening for those who pay their premiums faithfully, then need a specific cancer drug and find their insurance company has issued a new cancer drugs insurance denial. New, targeted therapies for the treatment of cancer are being developed almost daily. Unfortunately, there can be a significant lag between when these cancer drugs become available, and when an insurance company will recognize the drugs as more than experimental.

Since virtually all health insurance policies implement exclusions for experimental treatments, even if your doctor tells you a new cancer drug could potentially save your life, your insurance company may deny payment. As an example, one highly promising type of radiation known as proton beam therapy (PBT) is often challenged by insurance companies as being experimental. PBT can target radiation into tumors much more effectively than traditional radiation, damaging fewer surrounding tissues. While medical acceptance of this protocol is fairly widespread, insurance companies often deny the treatment, still considering it experimental.

Some forms of cancer treatment drugs can be denied under the guise of being “not medically necessary.” Even though insurance companies maintain they do not practice medicine, they routinely question the judgment of doctors regarding treatment. Not coincidentally, the denied treatments are often those that are more expensive—even when they have been shown to be more effective than less expensive treatments.

It can be totally disheartening to find that the company you paid to protect you has turned its back on you when you need help the most. Don’t give up! All you need is one person who cares enough about you and your future to fight on your behalf. That person is attorney Scott Glovsky. The Law Offices of Scott Glovsky has helped hundreds of individuals just like you who had reached their breaking point.

Scott Glovsky forces insurance companies to change their behavior—including their process of reviewing requests for medically necessary treatment, including a new cancer drug insurance denial. If you are in LA County—or anywhere throughout the state of California, for that matter—we can help. We have offices in Claremont and Pasadena for your convenience.

Cancer Drugs Subject to New Cancer Drugs Insurance Denial

While many drugs can be subject to an insurance denial, there are some specific cancer drugs that could be even more likely to be denied by your insurance company. These cancer drugs include:

• Rolvedon (eflapegrastim) is used to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. This drug was approved for use on 9/9/2022 by the FDA.
• Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is used to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies. This drug was approved for use on 3/23/2022 by the FDA.
• Zynlonta is a prescription medication used to treat adults who have been diagnosed with specific types of large B-cell lymphoma that have either returned or did not respond to prior cancer treatments. Zynlonta is the first and only CD19-targeted antibody drug used for large B-cell lymphoma. Zynlonta is manufactured by ADC Therapeutics and was just approved by the FDA in spring 2021. Based on the overall response rate to Zynlonta, accelerated approval was obtained by the FDA. Zynlonta meets a prior unmet need for treating adults with large B-cell lymphoma (DLBCL) that have had little success with other treatments. DLBCL is the most common type of non-Hodgkin lymphoma in the United States. It is an aggressive disease that progresses quickly. Zynlonta brings hope to many who had no success with other treatments. In fact, more than 40 percent of first-line DLBCL treatments fail, resulting in a poor prognosis. Because Zynlonta is expensive and new, insurance companies may deny requests by doctors for this drug.
• Jemperli (dostarlimab) received accelerated FDA approval as a drug to treat recurrent or advanced dMMR endometrial cancer. A GARNET study represented the largest dataset for an anti-PD-1 monotherapy treatment among women with endometrial cancer, showing an overall response rate of 42 percent. Jemperli is manufactured by GlaxoSmithKline, indicated for patients with dMMR recurrent or advanced endometrial cancer who have progressed on or are currently following prior treatment. During the clinical trials, Jemperli was shown to have a high response rate and durability of response. Since about one in four women with endometrial cancer experience a recurrence, or are initially diagnosed with an advanced case, Jemperli may be a true game-changer. GlaxoSmithKline is currently studying Jemperli for use as an earlier treatment, as well as in combination with other treatments for women with advanced solid tumors or metastatic cancers. Despite its success in clinical trials, insurance companies may deny payment for Jemperli because of its relative newcomer status.
• Fotivda (tivozanib) gained FDA approval on March 10, 2021, to be used in adults with relapsed or refractory advanced renal cell carcinoma after two prior systemic therapies have failed to work. Fotivda is a kinase inhibitor, evaluated in a large clinical trial that resulted in a median progression-free survival of 5.6 months compared with those treated with a different drug. Median overall survival was 16.4 months, with an objective response rate of 18 percent. For those for whom other treatments failed to work, Fotivda could significantly increase the survival and response rates for those with relapsed or refractory advanced renal cell carcinoma. Fotivda received FDA approval three weeks ahead of goal.  
• Pepaxto is an FDA approved drug used in combination with the steroid dexamethasone for the treatment of adults with relapsed or refractory myeloma. Patients for whom Pepaxto is approved are those who have received at least four prior lines of another type of therapy. The disease of these patients must be refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one CD38-directed monoclonal antibody. Pepaxto is the first anticancer peptide drug conjugate that garnered FDA approval. Pepaxto is expensive ($9,500 for a 20 mg vial) making it more likely insurance companies may deny the cancer drug despite significant evidence of efficacy.  In the clinical trials, the overall response rate for patients taking Pepaxto was 23.7 percent. The median duration of response was 4.2 months.
• Cosela (trilaciclib) is a cancer drug approved by the FDA in February 2021. Cosela is a first line therapy that reduces the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for extensive stage small cell lung cancer. Cosela has been found to protect bone marrow cells from the damage chemotherapy can cause by inhibiting an enzyme known as cyclin-dependent kinase. When bone marrow is protected by Cosela, chemotherapy is safer, allowing more patients to complete their course of chemotherapy treatment according to their doctor’s plan. Chemotherapy drugs kill cancer cells, but they can also damage healthy tissue, particularly bone marrow. When bone marrow is damaged, it produces fewer red and white blood cells and platelets. This increases the level of fatigue, infection, and bleeding among those undergoing chemotherapy treatment. Over the course of three studies, patients receiving Cosela had a significantly lower chance of developing severe neutropenia compared to those who received a placebo. Among those who had severe neutropenia, those taking Cosela had it for a significantly shorter period of time.
• Ukoniq is a drug used to treat adult patients with relapsed or refractory marginal zone lymphoma (MZL). The MZL patients prescribed the drug must have received at least one prior anti-CD20 based regimen or, patients with relapsed or refractory follicular lymphoma (FL) must have received at least three prior lines of systemic therapy. Ukoniq is the first and only oral inhibitor of phosphoinositide 3 kinase and casein kinase epsilon. Accelerated FDA approval was granted for Ukoniq in February 2021, based on the overall response rate. Despite treatment advances, MZL and FL remain incurable diseases with limited treatment options until Ukoniq. Ukoniq is now offering a new treatment option for these diseases and new hope for the outcome.
• Tepmetko is an oral kinase inhibitor approved to treat patients with metastatic non-small cell lung cancer (NSCLC). Tepmetko is the first and only FDA approved MET inhibitor with once-daily oral dosing. Tepmetko was developed by Merck, a German-based pharmaceutical company. Non-small cell lung cancer is the most common type of cancer across the globe, with more than two million new cases each and every year. In the United States in 2020, there were 228,000 new cases of NSCLC. Symptoms of NSCLC include chronic cough, chest pain, decreased appetite, chronic lung infections, unexplained weight loss, wheezing, and a cough that produces blood. About 85 percent of all lung cancers are NSCLC. The FDA granted accelerated approval for Tepmetko in February 2021.
• Elrexfio garnered FDA accelerated approval and was introduced to the United States in the first week of August 2023. Elrexfio is approved for relapsed or refractory multiple myeloma and is manufactured by Pfizer. Multiple myeloma is an aggressive, currently incurable blood cancer affecting bone marrow plasma cells that make antibodies to help the body fight infection. There are more than 35,000 new cases of multiple myeloma diagnosed in the U.S. each year, making it the second most common type of blood cancer. Even those who are “successfully” treated will almost certainly relapse at some point, often becoming resistant to the three primary classes of treatment. Elrexfio can give these patients a renewed chance to extend their lives and have an improved quality of life. Elrexfio is a fixed-dose subcutaneous drug; after 24 weeks of weekly treatments, Elrexfio can be administered every other week for long-term dosing. Elrexfio is a type of immunotherapy that binds to B-cell maturation antigens (BCMA) on myeloma cells and CD3 on T-cells. The drug then brings the T-cells and myeloma cells together, activating the T-cells to kill the myeloma cells. Current data showed the objective response rate to be about 61 percent, with those who continued every other week dosing after the initial 24 weeks achieving better outcomes than those who discontinued the drug.
• Talvey is another new drug used to treat relapsed or refractory multiple myeloma among patients who have received at least four prior therapies. Talvey received FDA approval just days before Elrexfio, on August 9, 2023. Like Elrexfio, the prior treatment regimens likely include a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Multiple myeloma that is not responding to other treatments or that has recurred may respond to Talvey, given via an injection under the skin, usually in the abdomen or thigh. Talvey, manufactured by Janssen Biotech, Inc., was also granted accelerated approval by the FDA. The most common side effects seen in clinical trials included changes in sense of taste, muscle and joint pain, fatigue, weight loss, and dry mouth. Talvey was generally well-tolerated by patients involved in the clinical trials. Talvey belongs to the bispecific antibody drug class that has transformed how certain cancers are treated. Bispecific antibodies target the G protein-coupled receptor Class C group 5 member D expressed on the surface of multiple myeloma cells, along with the CD3 receptor on the surface of T-cells. Talvey bridges the gap between T-cells and malignant myeloma cells by binding to those proteins.
• Vanflyta gained FDA approval on July 20, 2023, to be used as a part of a treatment regimen for those with newly diagnosed acute myeloid leukemia that meets specific criteria. Acute myeloid leukemia is an aggressive blood cancer; Vanflyta may be combined with chemotherapy among those diagnosed with AML who have a specific change in the FLT3 gene. About one-quarter of all those diagnosed with AML will have these FLT3 genetic mutations. In clinical trials, those with the FLT3 gene who received Vanflyta along with chemotherapy lived more than twice as long as those who received only chemotherapy. Vanflyta is only the second FDA-approved FLT3-targeted drug approved as a first-line treatment for those diagnosed with AML. The trials for Vanflyta were especially noteworthy, as they included many people over the age of 60 diagnosed with AML. As one of the most aggressive forms of leukemia, AML with the FLT3 mutation is even more aggressive, therefore, more deadly—and less likely to respond to traditional treatments. The QuANTUM-First trial, funded by Daiichi-Sankyo, the manufacturer of Vanflyta, had 539 participants. Forty percent of those participants were over the age of 60. Those who responded well to Vanflyta continued taking the drug for up to three years as maintenance therapy to prevent the disease from returning.
• Columvi is a new cancer medicine approved by the FDA on June 15, 2023. Columvi is used to treat diffuse large B-cell lymphoma or large B-cell lymphoma arriving from follicular lymphoma after the patient has tried two or more other types of therapy. Columvi treats this blood cancer among those who are not responding to traditional treatments or those whose cancer has returned. Columvi is manufactured by Genentech as a part of its portfolio of T-cell-engaging bispecific antibody treatments. Columvi gained accelerated FDA approval, based on the response rate seen in clinical trials. Genentech believes Columvi could change the manner in which aggressive lymphoma is treated, offering hope to those with the disease, along with an improved quality of life. Diffuse large B-cell lymphoma is an aggressive cancer that is known to be difficult to treat. DLBCL is the most common form of non-Hodgkin’s lymphoma in the United States. Patients with DLBCL who are unresponsive to traditional treatment as well as those who relapse and/or experience a rapid progression of the disease can significantly benefit from taking Columvi.
• Posluma, is used with positron emission tomography imaging in some patients with prostate cancer, gaining FDA approval on May 25, 2023. For men with prostate cancer with suspected metastasis, or those with recurrence, based on PSA levels, Posluma is used to detect and locate prostate cancer during PET scans. The imaging agent in Posluma is designed to bind to Prostate-Specific Membrane Antigens on prostate cancer cells, allowing physicians to accurately identify and locate those cells within the body. Common side effects of Posluma include increased blood pressure, injection site pain, and diarrhea. More severe, but less common side effects include blurry or tunnel vision, fast, irregular, or pounding heartbeats, loss of coordination, tremors, severe headache, and stiff muscles. Posluma may interact with other therapies that target the androgen pathways, such as androgen receptor antagonists. The manufacturer of Posluma is Blue Earth Diagnostics; Posluma is the first and only FDA-approved PSMA-targeted imaging agent with radiohybrid technology. Posluma became available in early June 2023, and is expected to become more available across the United States in the coming months. Two Blue Earth Diagnostics-sponsored Phase 3 trials provided the data for the FDA to approve Posluma. Results from these trials demonstrated high specificity in the detection of pelvic lymph nodes, and high detection rates even when PSA numbers were relatively low.
• Epkinly was approved by the FDA on May 19, 2023, as a cancer drug that treats relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy have not produced the desired effects. Epkinly was not tested on children and is only approved for adults. Epkinly has some potentially serious side effects, including cytokine release syndrome, that can be serious or life-threatening. Because of this risk, Epkinly is only administered on a “step-up” dosing schedule, which includes smaller dosages of the drug on days one and eight during the first cycle of treatment. Prior to each dose in cycle one, you will receive medications that will help reduce the risk of CRS. Epkinly can also cause serious neurologic problems that can be life-threatening. Because of the potential risks, you will be hospitalized for 24 hours after receiving the first full dose of Epkinly on day 15 of cycle 1 so that you can be carefully monitored for symptoms of neurologic problems and CRS. Infections, low blood cell counts, and anemia may also occur among those taking Epkinly. Epkinly is manufactured by Abbvie and Genmab.
• Zynyz was approved by the FDA on March 22, 2023, to treat metastatic or recurrent locally advanced Merkel cell carcinoma. Zynyz is considered a “programmed death receptor-1 blocking antibody” for adults with recurrent locally advanced or metastatic Merkel cell carcinoma. Merkel cell carcinoma is a rare disease in which malignant cells form in the skin. Those with a weakened immune system, and those with chronic sun exposure have a higher risk of Merkel cell carcinoma. A single, painless lump on sun-exposed skin is usually the first indication of Merkel cell carcinoma. Merkel cells are those found in the top layer of skin that are very close to the nerve endings that receive the sensation of touch. The head and neck, arms, legs, and trunk are areas most likely to develop Merkel cell carcinoma. Merkel cell carcinoma tends to grow quickly and has a high rate of metastasis. This leads to an overall poor prognosis—a five-year survival rate of only 14 percent among those diagnosed with metastatic MCC. The likelihood of being diagnosed with MCC is about 1 in 100,000 in the United States, although this number is rising, especially among adults over the age of 65. Zynyz is manufactured by Incyte who found that more than a third of all patients diagnosed with metastatic MCC will have high rates of mortality. Zynyz offers a first-line treatment option that may offer extended life expectancy as well as a higher quality of life for patients with difficult-to-treat metastatic MCC.
• Jesduvroq gained FDA approval in February 2023. Jesduvroq treats anemia caused by chronic kidney disease for adults who have been on kidney dialysis for at least four months. Anemia is common among those with chronic kidney disease as the kidneys do not make enough erythropoietin which the body needs to make red blood cells. Anemia is common among those on dialysis and can occur even before the kidneys fail. Those on kidney dialysis may become anemic due to a diet low in iron, or from blood loss during hemodialysis. At the end of each hemodialysis treatment, a small amount of blood is left behind in the artificial kidney. Over time, this can be a source of iron loss, causing anemia. Jesduvroq is the only oral HIF-PHI approved in the United States specifically for adults who have been receiving dialysis for at least four months and who have developed anemia as a result. Jesduvroq is the first innovative medicine for this type of anemia treatment in more than three decades. Chronic kidney disease affects 700 million patients across the globe. About one in seven patients with chronic kidney disease will develop anemia as a result of kidney dialysis.
• Jaypirca gained FDA approval on January 27, 2023, as a treatment for relapsed or refractory mantle cell lymphoma in adults who have already tried a BTK inhibitor as well as another line of systemic therapy. Mantle cell lymphoma is a rare form of lymphoma that originates from the mantle zone of the lymph node. This is an aggressive form of non-Hodgkin’s lymphoma that often occurs in an advanced stage with swelling of the lymph nodes. Some side effects seen among those involved in Jayprica drug trials included infections. Those at an increased risk of infection may receive other medications to decrease the risk of infection during treatment with Jaypirca. Jaypirca is considered the first medication of its kind to treat relapsed mantle cell lymphoma. Eli Lilly is the manufacturer of Jaypirca.

Promising New Drugs for Cancer Treatment

There are a number of new cancer drugs that have received FDA approval recently. Because they are still considered relatively new, many insurance companies may still refuse to pay for these drugs, even when a doctor believes the drug gives a cancer patient the very best chance of a future. If your insurer refuses to pay for a cancer drug that your physician believes you need, attorney Scott Glovsky can help. Some of the newer cancer drugs include: 

• The FDA approved pembrolizumab (Keytruda) for non-small cell lung cancer on January 26, 2023. Keytruda is also FDA-approved for the treatment of melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, and other types of cancer including as a post surgical treatment for resectable kidney cancer. As of March 2024, Keytruda is the best-selling drug in the world with annual sales over $25 billion.
  
• The FDA approved the drug sacituzumab govitecan-hziy for HR-positive breast cancer on February 3, 2023.  
• On March 3, 2023, the FDA approved abemaciclib for the treatment of early breast cancer that has a high risk of recurrence.  
• The FDA approved dabrafenib (Tafinlar, Novartis) for pediatric patients over a year old with low-grade glioma on March 22, 2023. 
• On March 22, 2023, the FDA granted accelerated approval for retifanlimab-dlwr (Zynyz, Incyte Corporation) is used for adult patients with metastatic or recurrent advanced Merkel cell carcinoma. 
• Belzutifan (Welireg) was approved in 2023 for advanced renal cell carcinoma.
• Eflornithine (IWILFIN) was approved in 2023 for adult and pediatric high-risk neuroblastoma.
• Pirtobrutinib (Jaypirca) was approved in 2023 for chronic lymphocytic leukemia and small lymphoma.
• Nirogacestat (OGSIVEO) was approved in 2023 for progressing desmoid tumors.
• Enzalutamide (Xtandi) was approved in 2023 for non-metastatic castration-sensitive prostate cancer.
• Capivasertib (Truqap) was approved in 2023 for locally advanced or metastatic breast cancer.
• Pembrolizumab (Keytruda) received approval in 2023 for adenocarcinoma and gastric adenocarcinoma.
• Repotrectinib (Augtyro) received approval in 2023 for non-small cell lung cancer.
• Fruquintinib (Fruzaqla) was approved in 2023 for adults with metastatic colorectal cancer.
• Tisotunab (Tivdak) was approved in 2024 for metastatic cervical cancer.
• Tovorafenib (Ojemda) was approved in 2024 for pediatric low-grade glioma.
• Lutetium Lu 177 (Lutathera) received approval in 2024 for pediatric GEP-NETS.
• Nogapendekin alfa (Anktiva) was approved in 2024 for unresponsive, invasive bladder cancer.
• Alectinab (Alecensa) received approval in 2024 for ALK-positive non-small cell lung cancer.
• Fam-trastuzumab (Enhertu) was approved in 2024 for metastatic HER2-positive solid tumors.
• Mirvetuximab (Elahere) received approval in 2024 for epithelial ovarian, fallopian tube, or peritoneal cancer.
• Obecabtagene (Aucatzyl) received approval in 2024 for relapsed B-cell acute lymphoblastic leukemia.
• Zanidatamab-hrii (Zihera) received approval in 2024 for metastatic HER2-positive biliary tract cancer.
• Ponatinib (Iclusig) was approved in 2024 for Philadelphia lymphoblastic leukemia.
• Zanubrutinib (Brukinsa) was approved in 2024 for refractory follicular lymphoma.
• Lisocabtagene maraleucel (Breyanzi) was approved in 2024 for follicular lymphoma.
• Blinatumomab (Blincyto) was approved in 2024 for CD19-positive Philadelphia chromosome-negative B-cell precursor lymphoblastic leukemia.
• Durvalumab (Imfinzi) was approved in 2024 for endometrial cancer.
• Selpercatinib (Retevmo) was approved in 2024 for metastatic thyroid cancer.
• Imetelstat (Rytelo) received approval in 2024 for transfusion-dependent anemia.
• Lisocabtagene maraleucel (Breyanzi) received approval in 2024 for refractory mantle cell lymphoma.
• Tarlatamab-dlle (Imdelltra) was approved in 2024 for small cell lung cancer.
• Lazertinib (Lazcluze) was approved in 2024 for non-small cell lung cancer.
• Dostarlimab-gxly (Jemperli) was approved in 2024 for endometrial cancer.
• Daratumumab (Darzalex) was approved in 2024 for newly diagnosed multiple myeloma, and approved in 2025 for high-risk smoldering multiple myeloma. 
• Encorafenib (Braftovi) was approved in 2024 for metastatic colorectal cancer.
• Adagrasib (Krazati) was approved in 2024 for metastatic colorectal cancer.
• Asciminib (Scemblix) received approval in 2024 for Philadelphia chromosome-positive chronic myeloid leukemia.
• Inavolisib (Itovebi) received approval in 2024 for metastatic breast cancer.
• Osimertinib (Tagrisso) received approval in 2024 for non-small cell lung cancer.
• Selpercatinib (Retevmo) was approved in 2024 for metastatic medullary thyroid cancer.
• Ribociclib (Kisquali) was approved in 2024 for early breast cancer at a high risk of recurrence. 

Oncology Drugs and Treatments That Were FDA Approved in 2025 or That We’ll Likely See in The Future

There are many exciting developments in oncology that we may see in 2025. Meanwhile, 2023 was the year of “circulating biomarkers,” which is the dynamic monitoring of the entire cancer journey—from detection to interception to monitoring. These ultra-sensitive technologies can detect and measure microscopic residual disease among those who have been through cancer treatments, allowing earlier interception strategies and better overall outcomes. “Precision immune-oncology,” is another exciting area in cancer research that will allow us to use immunotherapy in the most precise manner.  

Some of the oncology drugs that are expected to be released in early 2025 include:

• T-DXd, which is used to treat HER2-Low and -Ultralow Metastatic breast cancer. This drug is sold under the brand name Enhertu. The FDA approval was based on results from a phase 3 DESTINY-Breast06 trial.
• Acalabrutinib (brand name Calquence) was approved for use in previously untreated adults who are ineligible for hematopoietic stem cell transplantation in conjunction with Rituxan and rituximab or as a single agent for previously treated adults. Approval was based on the phase 3 ECHO trial.
• Celltrion USA to treat osteolytic bone lesions of multiple myeloma, osteolytic bone metastases of solid tumors, giant cell bone tumors, and hypercalcemia of malignancy.

Cancer drugs approved in 2025 include:

• Ziftomenib (Komzifti), manufactured by Kura Oncology, was recently approved by the FDA on November 13, 2025, for adults with relapsed or refractory acute myeloid leukemia (AML) who have a susceptible nucleophosmin 1 mutation (NPM1) and have no satisfactory alternative treatments. Komzifti is a targeted therapy drug that is a menin inhibitor, which means it works by blocking a protein called menin. Komzifti is the first and only menin inhibitor approved for this condition. 
• Daratumumab and hyaluronidase-fihj (Darzalex, Faspro), manufactured by Janssen Biotech, Inc., gained FDA approval on November 6, 2025, for adults with high-risk smoldering multiple myeloma. Darzalex is a type of monoclonal antibody, a laboratory-made protein designed to function like a natural antibody. It works by targeting a specific protein called CD38, which is abundantly expressed on the surface of multiple myeloma cells. When Darzalex binds to CD38, it directly kills the cancer cells, activating the body’s immune system to help find and destroy them. 
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• Revumenib (Revuforj), manufactured by Syndax Pharmaceuticals, Inc., was approved by the FDA on October 24, 2025, as a treatment for relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 (NPM1) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. In certain leukemias, a genetic mutation causes the menin protein to interact with the KMT2A gene, leading to the uncontrolled growth of leukemia cells. By blocking menin, Revuforj prevents this interaction, slowing or stopping the growth of cancer cells.
• Belantamab mafodotin-blmf (Blenrep), manufactured by GlaxoSmithKline, was approved by the FDA on October 23, 2025, as a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Blenrep works by targeting a protein called B-cell maturation antigen on multiple myeloma cells, delivering a chemotherapy agent to destroy the cancer cells.
• Cemiplimab-rwlc (Libtayo), manufactured by Regeneron Pharmaceuticals, Inc., was approved by the FDA on October 8, 2025 for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. Libtayo works by blocking the PD-1 protein, which helps the immune system identify and kill cancer cells. 
• Lurbinectedin (Zepzelca), manufactured by Jazz Pharmaceuticals, in combination with atezolizumab (Tecentriq) by Genentech, Inc., was approved by the FDA on October 2, 2025, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab. Zepzelca is an alkylating agent that works by binding to the DNA within cancer cells, thereby damaging the DNA and preventing the cells from dividing, ultimately causing them to die.
• Imlunestrant (Inluriyo), manufactured by Eli Lilly and Company, was approved by the FDA on September 25, 2025, as an estrogen receptor antagonist for adults with estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
• Pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), manufactured by Merck, gained FDA approval on September 19, 2025, as a subcutaneous injection for adults and pediatric patients 12 years and older for solid tumor indications approved for Keytruda. Keytruda Qlex is an immune checkpoint inhibitor, a type of immunotherapy that contains the active ingredient pembrolizumab, a monoclonal antibody that blocks the PD-1 protein on immune cells. This action essentially “removes the brakes” from the immune system, allowing the body’s T-cells to better recognize and attack cancer cells.
• Selumetinib (KOSELUGO), manufactured by AstraZeneca Pharmaceuticals LP, was approved by the FDA on September 10, 2025, for pediatric patients aged one year and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas. KOSELUGO is not a “traditional” chemotherapy drug. It is a kinase inhibitor, specifically, a MEK1/2 inhibitor that works by blocking specific proteins that encourage tumor cells to grow and multiply.
• Gemcitabine intravesical system (Inlexzo), manufactured by Janssen Biotech, Inc., was approved by the FDA on September 9, 2025, for adults with Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS), with or without papillary tumors. Gemcitabine is co-packaged with a urinary catheter used for insertion through the urinary catheter into the bladder.
• Zongertinib (Hernexeos), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., was granted accelerated approval by the FDA on August 8, 2025, as a kinase inhibitor for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC), whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, who have received prior systemic therapy. 
• Dordaviprone (Modeyso), manufactured by Jazz Pharmaceuticals, Inc., was granted FDA approval on August 6, 2025, as a protease activator for adult pediatric patients one year old and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Modeyso is the first and only approved systemic treatment for a rare and aggressive type of brain tumor that has progressed after prior therapy.
• Sunvozertinib (Zegfrovy), manufactured by Dizal Pharmaceutical Co., Ltd., gained FDA approval on July 2, 2025, for adult patients with locally advanced or metastatic non-small cell lung cancer that has epidermal growth factor receptor mutations, whose disease has progressed on or after platinum-based chemotherapy. Zegfrovy is a tyrosine kinase inhibitor that works by blocking the EGFR gene and can slow down or halt the growth of cancer cells.
• Linvoseltamab-gcpt (Lynozyfic), manufactured by Regeneron Pharmaceuticals, Inc., gained FDA approval on July 2, 2025, to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Lynozyfic is a T-cell engager that works by simultaneously binding to two different proteins: BCMA, found on the surface of multiple myeloma cancer cells, and CD3, found on the surface of T-cells. By acting as a bridge between these two cells, Lynozyfic brings the T-cells into direct contact with the cancer cells, activating the T-cells to attack and destroy the myeloma cells.
• Deatopotamab deruxtecan-dlnk (Datroway), manufactured by Daiichi Sankyo, Inc., gained FDA approval on June 23, 2025, for adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy. Datroway works by delivering a chemotherapy drug directly to cancer cells that have a specific protein called TROP-2 on their surface. This targeted approach kills cancer cells while minimizing damage to healthy cells. It was approved on January 17, 2025, to treat unresectable or metastatic breast cancer. 
• Tafasitamab-cxix (Monjuvi), manufactured by Incyte Corporation, in combination with lenalidomide and rituximab, was approved by the FDA on June 18, 2025, for the treatment of adults with relapsed or refractory follicular lymphoma. Monjuvi is a monoclonal antibody that targets the CD19 protein, which is found on the surface of B cells, including those involved in cancer. Once attached, it signals the body’s immune system to attack and destroy the cancer cells.
• Pembrolizumab (Keytruda), manufactured by Merck, gained FDA approval on June 12, 2025, to treat adults with resectable locally advanced head and neck squamous cell carcinoma, whose tumors express a PD-L1 Combined Positive Score greater than one, as a single agent neoadjuvant treatment, or continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery.  Keytruda works by blocking the PD-1 protein, which cancer cells can use to evade detection by the immune system. It is administered intravenously and approved for numerous cancers, including certain types of lung, skin, breast, and colorectal cancers.
• Mitomycin intravesical solution (Zusduri), manufactured by UroGen Pharma, was approved on June 12, 2025, for use in adult patients with recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer. Zusduri uses UroGen’s proprietary RTGel technology, which is a reverse-thermal hydrogel. It is administered as a chilled liquid into the bladder through a urinary catheter. Once inside the bladder, the solution warms to body temperature and transforms into a semi-solid gel, which allows the active chemotherapy agent, mitomycin, to remain in prolonged contact with the bladder tissue.
• Taletrectinib (Ibtozi), manufactured by Nuvation Bio Inc., was approved by the FDA on June 11, 2025, as a kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. Ibtozi is a tyrosine kinase inhibitor that blocks abnormal ROS1 fusion proteins, which fuel the growth of cancer cells. It is designed to overcome resistance mutations found in older ROS1 inhibitors, and shows activity in the brain, which can help treat brain
• Darolutamide (Nubeqa), manufactured by Bayer Healthcare Pharmaceuticals, Inc., gained FDA approval on June 3, 2025, for the treatment of metastatic castration-sensitive prostate cancer. Prostate cancer cells rely on androgen hormones, like testosterone, to grow. Nubeqa works as a non-steroidal anti-androgen by binding to the androgen receptors on cancer cells, blocking testosterone from attaching and thereby preventing cell growth, which slows the cancer’s growth or spread.
• Retifanlimab-dlwr (Zynyz), manufactured by Incyte Corporation, was approved by the FDA on May 15, 2025. The drug is a first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. Zynyz is a type of monoclonal antibody called a programmed death receptor-1 blocking antibody. The drug targets the PD-1 receptors on T-cells, blocking the interaction with cancer cells, thus allowing T-cells to become active and attack cancer cells more effectively.
• Telisotuzumab vedotin-tlly (Emrelis), manufactured by AbbVie Inc., was approved by the FDA on May 14, 2025, as a c-Met-directed antibody and microtubule inhibitor conjugate for adults with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received a prior systemic therapy. Emrelis works like a “guided missile” to specifically target cancer cells, while minimizing harm to healthy cells.
• Belzutifan (Welireg), manufactured by Merck & Co., Inc., received FDA approval on May 14, 2025, for use in adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma. This is the first FDA approval of an oral therapy for PPGL. Welireg blocks a specific protein that contributes to cancer growth, and is also approved for the treatment of von Hippel-Lindau disease and advanced renal cell carcinoma.
• Avutometinib and defactinib (Avmapki Fakzynja Co-pack), manufactured by Verastem, Inc., gained FDA approval on May 8, 2025, to treat adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy. The drug is the first and only FDA-approved medication for this particular condition. It is a combination of two different kinase inhibitors that work together to block signaling pathways that drive cancer cell growth and drug resistance, slowing the progression of the disease.
• Penpulimab-kcqx (Brand-name Anike in China), manufactured by Biopharma Co., Ltd., gained FDA approval on April 23, 2025, as a first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. 
• Nivolumab (Opdivo), manufactured by Bristol Myers Squibb Company, was approved by the FDA on April 11, 2025, as a first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma. Opdivo with ipilimumab (Yervoy) gained FDA approval on April 8, 2025, for adult and pediatric patients 12 years old and older with unresectable or metastatic microsatellite colorectal cancer. Opdivo is a type of immunotherapy that acts as an immune checkpoint inhibitor, helping to unmask cancer cells to the immune system. It is a monoclonal antibody that helps the body’s own immune system to attack cancer cells by blocking certain proteins. Opdivo is also approved to treat melanoma, non-small cell lung cancer, malignant pleural mesothelioma, kidney cancer, Hodgkin’s lymphoma, bladder cancer, liver cancer, and certain types of colorectal, stomach, and esophageal cancers.
• Durvalumab (Imfinzi), manufactured by AstraZeneca, in combination with gemcitabine and cisplatin, was approved by the FDA on March 28, 2025, for the treatment of adults with muscle-invasive bladder cancer. Imfinzi is also used for biliary tract cancer, endometrial cancer, hepatocellular carcinoma, and lung cancer, and may be used in clinical trials for other types of cancer. Imfinzi is an immunotherapy cancer drug that blocks the PD-L1 protein, which is found on some cancer cells, allowing T-cells to find and kill cancer cells more effectively.
• Lutetium Vipivotide tetraxetan (Pluvicto), manufactured by Novartis Pharmaceuticals Corporation, gained expanded FDA approval to include adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor therapy and who are considered appropriate to delay taxane-based chemotherapy. Pluvicto works by using a radioactive substance attached to a molecule that binds PSMA on cancer cells, delivering radiation to damage and kill them.
• Cabozantinib (Cabometyx), manufactured by Exelixis, Inc., was approved by the FDA on March 26, 2025, for use in adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced, or metastatic well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors. Cabometyx is also approved to treat kidney cancer, liver cancer, and thyroid cancer. Treatment must be stopped at least three weeks prior to any scheduled surgery to reduce the risk of hemorrhage.
• Vimseltinib (brand name Romvimza) for Tenosynovial giant cell tumors.
• Acalabrutinib (Calquence) received FDA approval on January 16, 2025, for mantle cell lymphoma.
• Sotorasib (Lumakras) was approved on January 16, 2025, to treat adults with KRAS G12C-mutated metastatic colorectal cancer.
• Treosulfan (Grafapex) was approved on January 21, 2025 as a preparative regimen for stem cell transplantation in adult and pediatric patients with acute myeloid leukemia.
• Fam-trastuzumab deruxtecan-nxki (Enhertu) was approved on January 27, 2025 to treat breast cancer.
• Mirdametinib (Gomekli) was approved on February 11, 2025 to treat neurofibromatosis.
• Brentuximab (Adcetris) was approved on February 12, 2025, to treat relapsed or refractory large B-cell lymphoma.
• Denosumab – dssb (brand name Xbryk) was approved by the FDA on February 13, 2025, for hypercalcemia of malignancy, giant cell tumor of bone, osteolytic bone metastases of solid tumors, and osteolytic bone lesions of multiple myeloma.

How the Law Offices of Scott Glovsky Can Assist with New Cancer Drugs Insurance Denial

Even though your insurer essentially agreed to pay for any medical treatment necessary to save your life or that of a loved one—or to increase their quality of life—insurance companies often make decisions as to whether the treatment is medically necessary. Despite the success of many of these new cancer drugs and despite the fact that they all have FDA approval, many insurance companies still refuse to approve these life-saving drugs.

As noted, insurers routinely claim that there is a lack of medical necessity for a drug, or assert that a cancer drug is “investigational” or “experimental,” to avoid paying for a treatment that could potentially save a life. There should be a definition of the term “medical necessity” in your health insurance policy, so it could be beneficial to look it over. The language may claim the drug is not necessary for or appropriate to the diagnosis, treatment, or relief of your illness or that it is not within the generally accepted standards of medical care in your community.  

It could also say that the cost-effectiveness of the drug is not proven, or that there are alternative (cheaper) drugs to treat your illness. Attorney Scott Glovsky deals with these types of denials on a regular basis, fighting hard to make the insurer re-evaluate the situation, always with the goal of getting the denial reversed.  

A letter detailing why the drug is medically necessary for your type of cancer is important in this fight, whether your insurer is claiming the drug is not medically necessary or whether your insurer is claiming the drug is experimental or investigational. Such a letter, along with a strong attorney like Scott Glovsky, who will never give up when the fight gets difficult, provides you with your best chance of a denial reversal.

Scott Glovsky will fight for you and your right to receive potentially life-saving drug therapy. We will work with you to examine your medical needs, evaluate the case law dealing with your situation, and determine the best path forward to challenge your insurance company’s new cancer drugs insurance denial. Contact the Law Offices of Scott Glovsky today in LA County or across the state of California.