The FDA enters the fourth quarter of 2026 with a packed agenda, including a first-of-its-kind cancer immunotherapy and a breast cancer drug that Roche believes could become its largest seller. The agency also remains under an acting commissioner, with the nominee's confirmation uncertain.
Summit and Akeso's ivonescimab faces a Nov. 14 decision for EGFR-mutated non-small cell lung cancer. The drug drew attention after beating Keytruda in a China-only study, but analysts question the reliability of those results and note the primary analysis did not show a clear survival benefit. The FDA may scrutinize the exploratory nature of the later analysis.
Roche's giredestrant has two decision dates: Nov. 30 for adjuvant use and Dec. 18 for metastatic disease. In the adjuvant trial, combining giredestrant with hormone therapy reduced recurrence or death by 30% versus hormone therapy alone. Roche executives have touted the drug's potential, though oral SERDs as a class have yet to prove as broadly impactful as hoped.
The BioPharma Dive article also lists decisions tied to GSK and Gilead, and a potential "functional cure" for hepatitis B, though details are not provided in the excerpt. The broader context is leadership instability: acting commissioner Kyle Diamantas has steadied the agency, but nominee Heidi Overton faces a tight confirmation window before the Senate recess.