FDA red and green lights: November 2025

November turned out to be one busy month on the oncology regulatory front, delivering double the number of FDA approvals seen in each of the previous two months. Among them was the accelerated nod for Bayer's Hyrnuo (sevabertinib) in second-line HER2-mutant NSCLC, followed by a full approval for Amgen's Imdelltra in second-line extensive-stage SCLC, and the rapid periadjuvant approval of the Padcev plus Keytruda combination in muscle-invasive bladder cancer. 

AstraZeneca, meanwhile, strengthened its immuno-oncology hand with Imfinzi’s periadjuvant approval in gastric and GEJ cancers, marking a notable success in an area where Keytruda failed to show benefit. Meanwhile, the expansion of Koselugo into adults with NF1-PN adds further weight to the company’s rare disease portfolio. 

Elsewhere in haematology, Kura’s Komzifti (ziftomenib) landed an approval in the same indication as Syndax’s Revuforj got last month, NPM1-mutated AML.

Rounding out the month’s activity, Johnson & Johnson's Darzalex picked up a clearance in high-risk smouldering myeloma and AbbVie and Genmab's Epkinly secured full approval in second-line follicular lymphoma, while also seeing its accelerated approval confirmed in the third-line setting.

Safety considerations 

For Hyrnuo, the approval sets up an immediate battle with Boehringer Ingelheim’s Hernexeos, approved earlier in the same setting. The two drugs posted broadly similar efficacy but their safety differences could matter: Hernexeos’ label includes warnings for hepatotoxicity, ILD and cardiac dysfunction, while Hyrnuo’s includes warnings for diarrhoea, ILD, ocular events and pancreatic enzyme elevations. 

For Kura, the comparison with Syndax’s Revuforj is more stark. Revuforj carries a boxed warning for QTc prolongation, whereas Komzifti includes QTc prolongation only as a standard warning. 

Fast approvals 

For Imdelltra and the Padcev/Keytruda regimen, the FDA reviews were strikingly fast. Imdelltra won full approval two weeks after its BLA acceptance, supported by the Dellphi-304 study, which showed a median overall survival benefit of 13.6 months versus 8.3 months for chemotherapy. 

As for Padcev/Keytruda, the combo was cleared on the strength of the EV-303 trial, more than four months before its 7 April 2026 PDUFA date. In the study, the combo cut risk of recurrence, progression or death by 60% versus surgery alone.

Selected November 2025 US regulatory decisions in oncology

Source: OncologyPipeline