FDA red and green lights: October 2025

October saw four US novel oncology approvals, including a milestone nod for the first combination therapy cleared for first-line maintenance in extensive-stage small cell lung cancer. Jazz earned this distinction with its Zepzelca and Tecentriq pairing.

In a surprising turn, GSK’s Blenrep received approval in multiple myeloma, just months after an FDA advisory committee voted against it. Rounding out the month’s decisions, Regeneron’s Libtayo gained clearance in adjuvant cutaneous squamous cell carcinoma, while Syndax’s Revuforj won in NPM1-mutated AML, edging out Kura in the menin inhibitor race.

Blenrep win

After a setback at an FDA advisory committee meeting earlier this year Blenrep’s prospects had looked bleak. The panel voted against a second-line approval based on data from the Dreamm-7 and Dreamm-8 studies, citing safety concerns.

Yet GSK secured a three-month extension to the review timeline while submitting additional data, ultimately earning approval, albeit not in the originally intended treatment line. The BCMA-directed ADC is now authorised for third-line multiple myeloma, and GSK says it remains confident of expanding its use into earlier settings.

Meanwhile, Syndax scored a big win in October with the approval of Revuforj in NMP1-mutated AML, a population roughly three times larger than that which accounts for the drug's previous approval, KMT2A-mutant leukaemia.

The latest decision put Syndax ahead of Kura Oncology, whose rival menin inhibitor is awaiting a verdict in the NMP1-mutated population this month. Although both drugs yielded comparable results in their respective Augment-101 and Komet-001 trials, Kura is positioning its candidate as safer, particularly with Revuforj carrying a QTc interval prolongation warning.

First approvals

Jazz’s Zepzelca, originated by Pharmamar, became the first FDA-approved combination for first-line maintenance treatment of SCLC when administered with Tecentriq. But this regimen also comes with some safety issues as in the Imforte trial two patient deaths were deemed related to therapy, and 26% experienced grade 3/4 adverse events.

Finally, Regeneron’s Libtayo got was approved for adjuvant cutaneous squamous cell carcinoma, an indication where it seems likely to face little competition in the near term.

Selected October 2025 US regulatory decisions in oncology

Source: OncologyPipeline.