MSK-led research resulted in 11 new FDA approvals for cancer drugs in 2025
Memorial Sloan Kettering Cancer Center
The U.S. Food and Drug Administration (FDA) approved 11 cancer drugs in 2025, based on clinical trials in which MSK played a pivotal role.
These approvals spanned therapies for a range of solid tumors and blood cancers and included treatments for both common and rare types of tumors. They are listed in chronological order.
(Note: The FDA uses the term “accelerated approval” for drugs that treat diseases lacking effective treatments. These criteria are slightly different from a standard approval. The term “full approval” applies to drugs that had previously been granted “conditional approval.”)
Sarcoma
For adults with a rare condition called tenosynovial giant cell tumor (TGCT), the FDA approved vimseltinib (RomvimzaTM) on February 14. Sarcoma oncologist William Tap, MD, Chief of the Sarcoma Medical Oncology Service at MSK, led the international phase 3 trial that resulted in the drug’s approval. Vimseltinib is a type of targeted therapy called a kinase inhibitor. TGCT, which is also called pigmented villonodular synovitis, is a tumor of the tissue that lines the joints.
Prostate Cancer
For patients with metastatic prostate cancer that has stopped responding to hormone treatment, the FDA expanded the approval on March 28 for the drug 177Lu-PSMA-617 (Pluvicto®) so it can be used earlier in treatment. Previously, the drug was approved only for patients with metastatic cancer that had stopped responding to both hormone therapy and taxane-based chemotherapy. But findings from a phase 3 clinical trial led by MSK medical oncologist Michael Morris, MD, found that the treatment could be given sooner and could help patients avoid the side effects of chemotherapy. 177Lu-PSMA-617, a radiopharmaceutical drug, includes a molecule that selectively seeks out a protein on the surface of cancer cells and delivers radiation that damages DNA and destroys the cells.
Ovarian Cancer
The first drug for a rare and difficult-to-treat type of ovarian cancer was granted accelerated approval by the FDA on May 8. The treatment, called avutometinib plus defactinib (AvmapkiTM FakzynjaTM Co-pack), was developed to treat low-grade serous ovarian cancer (LGSOC). The phase 2 clinical trial that resulted in the approval was led in the United States by MSK gynecologic medical oncologist Rachel Grisham, MD. Dr. Grisham is also leading the ongoing global randomized confirmatory phase 3 trial.
Skin Cancer
For people with locally advanced head and neck squamous cell carcinoma, the FDA approved the immunotherapy drug pembrolizumab (Keytruda®) to be given before and after surgery in combination with standard therapy. The June 12 approval was based on a phase 3 clinical trial designed and co-led by MSK radiation oncologist Nancy Lee, MD. The trial found that adding pembrolizumab to radiation therapy and chemotherapy significantly reduced the risk of disease progression, recurrence, or death. Pembrolizumab is an immunotherapy drug called a checkpoint inhibitor and is used to treat a number of different cancers.
Breast Cancer
For people with advanced ER-positive, HER2-negative breast cancer that has an ESR1 mutation and has become resistant to standard hormone therapy, the FDA approved imlunestrant (InluriyoTM) on September 25. The approval was based on an international, phase 3 clinical trial chaired by MSK medical oncologist Komal Jhaveri, MD, FACP. Imlunestrant is a next-generation selective estrogen receptor degrader and appears to be especially effective when combined with a second drug, a CDK4/6 inhibitor called abemaciclib (Verzenio®).
Leukemia
For patients 1-year-old and older who have leukemia that has come back after treatment and whose cancer carries a molecular change called an NPM1 mutation, the FDA approved revumenib (Revuforj®) on October 24. The drug was approved in 2024 for treating the same class of patients whose cancer carries another molecular change, called a KMT2A translocation. The trial that brought about the drug’s approval for both groups of patients was led by Eytan Stein, MD, Chief of MSK’s Leukemia Service. The early research on this new class of drugs, called menin inhibitors, also was done at MSK.
Follicular Lymphoma
For people with follicular lymphoma that has come back or stopped responding to other treatments, the FDA approved a new drug called epcoritamab (EpkinlyTM) in combination with two older drugs — rituximab (Rituxan®) and lenalidomide (Revlimid®). The international phase 3 trial that resulted in the approval on November 18 was led by MSK lymphoma specialist Lorenzo Falchi, MD. Epcoritamab is novel type of immunotherapy called a T cell–engaging, bispecific antibody.
Lung Cancer
For adults with advanced small cell lung cancer that has spread after platinum-based chemotherapy, the FDA granted full approval on November 19 to tarlatamab (Imdelltra®), a targeted immunotherapy drug. The approval was based on an international phase 3 clinical trial led by MSK scientist and thoracic medical oncologist Charles Rudin, MD, PhD. Tarlatamab received accelerated approval from the FDA in May 2024, based on results from a phase 2 trial.
Bladder Cancer
For people with muscle-invasive urothelial carcinoma (a type of bladder cancer), the FDA approved enfortumab vedotin (Padcev®) in combination with the immunotherapy drug pembrolizumab (Keytruda®) to be given before and after surgery. The November 21 approval was based on a phase 3 clinical trial that showed the drug combination reduced patients’ risk of death by half when used before and after surgery to remove the bladder. The trial was led by MSK genitourinary oncologist and bladder cancer specialist Jonathan Rosenberg, MD. The new approval greatly expanded the number of people with bladder cancer who are eligible for enfortumab vedotin, which was approved by the FDA in 2023 for metastatic bladder cancer.
Gastric Cancer
For people with early-stage stomach (gastric) cancer and gastroesophageal cancer, durvalumab (Imfinzi®) in combination with chemotherapy has become the first and only immunotherapy approved for use for these cancers before and after surgery. The global phase 3 clinical trial that resulted in the November 25 approval was led by Yelena Janjigian, MD, Chief of Gastrointestinal Medical Oncology at MSK. Results from the trial showed that this treatment prevents the cancer from coming back after surgery. Durvalumab, a checkpoint inhibitor, was previously approved for treating several other types of cancer.
Marginal Zone Lymphoma
For people with a slow-growing, rare form of non-Hodgkin lymphoma called marginal zone lymphoma that has returned after other treatments, the FDA approved lisocabtagene maraleucel (Breyanzi®). The December 4 approval was based on results from a phase 2 clinical trial led by MSK hematologist-oncologist Lia Palomba, MD. Lisocabtagene maraleucel is a CAR T therapy. In 2024, it was approved for another type of non-Hodgkin known as mantle cell lymphoma, also based on a clinical trial led by Dr. Palomba.
Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.