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FDA Updates for May 2025
On May 15, 2025, the FDA approved retifanlimab-dlwr (Zynyz, Incyte Corporation) 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) evaluated in POD1UM-303/InterAACT 2 (NCT04472429). 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.
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On May 14, 2025, the FDA granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, NSCLC with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [VENTANA MET (SP44) RxDx Assay (Roche Diagnostics)], who have received a prior systemic therapy based on the LUMINOSITY study (NCT03539536). Read More
On May 14, 2025, the FDA also approved belzutifan (Welireg, Merck & Co., Inc.) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). This represents the first FDA approval of an oral therapy for PPGL with efficacy evaluated in LITESPARK-015 (NCT04924075). Read More
On May 8, 2025, the FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy based on the RAMP-201 trial (NCT04625270). Read More
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