FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer

On June 3, the FDA approved darolutamide for metastatic castration-sensitive prostate cancer.

For more information, read the FDA announcement and the Bayer Healthcare Pharmaceuticals Inc press release.

Posted on 6/3/2025

FDA Approves Retifanlimab-dlwr With Carboplatin and Paclitaxel and as a Single Agent for Squamous Cell Carcinoma of the Anal Canal

On May 15, the US Food and Drug Administration (FDA) approved retifanlimab-dlwr with carboplatin and paclitaxel for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also approved retifanlimab-dlwr, as a single agent, for adults with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.

For more information, read the FDA announcement and the Incyte Corporation press release.

Posted on 5/16/2025

FDA Grants Accelerated Approval to Telisotuzumab Vedotin-tllv for NSCLC With High c-Met Protein Overexpression

On May 14, the US Food and Drug Administration (FDA) granted accelerated approval to telisotuzumab vedotin-tllv, a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer with high c-Met protein overexpression, as determined by an FDA-approved test, who have received a prior systemic therapy.

For more information, read the FDA announcement and the AbbVie Inc. press release.

Posted on 5/16/2025

FDA Approves Belzutifan for Pheochromocytoma or Paraganglioma

On May 14, the US Food and Drug Administration (FDA) approved belzutifan for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

For more information, read the FDA announcement and the Merck & Co., Inc. press release.

Posted on 5/16/2025

FDA Grants Accelerated Approval to the Combination of Avutometinib and Defactinib for Select Patients With Ovarian Cancer

On May 8, the US Food and Drug Administration (FDA) granted accelerated approval to the combination of avutometinib and defactinib for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

For more information, read the FDA announcement and the Verastem press release.

Posted on 5/19/2025

FDA Approves Penpulimab-kcqx for Non-Keratinizing Nasopharyngeal Carcinoma

On April 23, the US Food and Drug Administration (FDA) approved penpulimab-kcqx with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma and as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy.

For more information, read the FDA announcement.

Posted on 4/24/2025

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic Hepatocellular Carcinoma

On April 11, the US Food and Drug Administration (FDA) approved nivolumab with ipilimumab for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

For more information, read the FDA announcement or the Bristol Myers Squibb press release.

Posted on 4/11/2025

FDA Approves Larotrectinib for Adult and Pediatric Patients With NTRK Gene Fusion-Positive Solid Tumors

On April 10, the US Food and Drug Administration (FDA) approved larotrectinib, a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity.

For more information, read the Bayer press release.

Posted on 4/11/2025

FDA Expands Pluvicto’s Metastatic Castration-Resistant Prostate Cancer Indication

On March 28, the US Food and Drug Administration (FDA) expanded the indication for lutetium Lu 177 vipivotide tetraxetan 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 are considered appropriate to delay taxane-based chemotherapy.

For more information, read the FDA announcement or the Novartis press release.

Posted on 4/8/25

FDA Approves Nivolumab With Ipilimumab for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

On April 8, the US Food and Drug Administration (FDA) approved nivolumab with ipilimumab for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient colorectal cancer.

For more information, read the FDA announcement.

Posted on 4/8/25