The U.S. Food and Drug Administration approved 10 new cancer therapies in 2025, spanning solid tumors and blood cancers, after pivotal clinical trials showed significant benefits for patients. The approvals include treatments for both common malignancies and rare conditions, offering new hope for people with hard to treat cancers.
Among the notable approvals, the FDA greenlit vimseltinib (Romvimza) for tenosynovial giant cell tumor, a rare joint tumor, on February 14. The international phase 3 trial was led by sarcoma specialist Dr. William Tap. For metastatic prostate cancer, the agency expanded approval of 177 Lu-PSMA-617 (Pluvicto) on March 28, allowing earlier use before chemotherapy. The phase 3 study, led by Dr. Michael Morris, showed the radiopharmaceutical could help patients avoid chemotherapy side effects. In May, the FDA granted accelerated approval to avutometinib plus defactinib (Avmapki and Fakzynja) for low-grade serous ovarian cancer, the first drug specifically for this rare ovarian cancer type. The U.S. portion of the phase 2 trial was led by Dr. Rachel Grisham.
In June, the FDA approved pembrolizumab (Keytruda) for locally advanced head and neck squamous cell carcinoma, to be given before and after surgery with standard therapy. The phase 3 trial, co-led by Dr. Nancy Lee, found adding the immunotherapy significantly reduced the risk of disease progression, recurrence, or death. For advanced ER-positive, HER2-negative breast cancer with an ESR1 mutation, the FDA approved imlunestrant (Inluriyo) on September 25. The phase 3 trial was chaired by Dr. Komal Jhaveri, and the drug appears especially effective when combined with a CDK4/6 inhibitor. In October, the FDA approved revumenib (Revuforj) for children as young as one year old with relapsed leukemia carrying an NPM1 mutation. The trial was led by Dr. Eytan Stein, and early research on this menin inhibitor class was conducted at the same center.
In November, the FDA approved epcoritamab (Epkinly) combined with rituximab and lenalidomide for relapsed follicular lymphoma, based on a phase 3 trial led by Dr. Lorenzo Falchi. The same month, tarlatamab (Imdelltra) received full approval for advanced small cell lung cancer after platinum chemotherapy, following a phase 3 trial led by Dr. Charles Rudin. Also in November, durvalumab (Imfinzi) became the first immunotherapy approved for early stage gastric and gastroesophageal cancers before and after surgery, based on a global phase 3 trial led by Dr. Yelena Janjigian. Finally, on December 4, the FDA approved lisocabtagene maraleucel (Breyanzi), a CAR T therapy, for marginal zone lymphoma, based on a phase 2 trial led by Dr. Lia Palomba.
These 2025 approvals mark a significant step forward in precision oncology, offering targeted options for patients who previously had few. Researchers are now focused on expanding these therapies to earlier stages of disease and combining them with other treatments to improve outcomes further. The momentum suggests even more breakthroughs are on the horizon for patients with cancer.