FDA red and green lights: May 2025

May saw five FDA oncology approvals, the most notable of which was AbbVie’s accelerated nod for Emrelis, the first therapy for cMet-overexpressing NSCLC. One question is how much the product will sell, given that its use is limited to cMet-high patients, who account for around half of overexpressers. Meanwhile, Incyte’s latecomer anti-PD-1 drug Zynyz got a thumbs up in another niche, squamous cell carcinoma of the anal canal (SCAC), both as a first-line chemo combo and as monotherapy for relapsed patients. This was the group’s second attempt here, after being knocked back in relapsed SCAC in 2021. An even tinier use now beckons for Merck & Co’s Welireg: the rare neuroendocrine tumours pheochromocytoma or paraganglioma. This is unlikely to make much difference to Welireg’s sales, which totalled $509m in 2024, driven by use in renal cancer. Merck hopes that the drug, gained via its $1bn acquisition of Peloton, will become a blockbuster. Finally, Verastem’s Avmapki Fakzynja (avutometinib and defactinib) gained accelerated approval for KRAS-mutated recurrent low-grade serous ovarian cancer, a rare form of the disease. The company, which raised $75m in April, now faces the prospect of a solo launch; it’s also testing the combo in pancreatic cancer.

Selected May 2025 US regulatory decisions in oncology

Source: OncologyPipeline.