FDA held its first drug advisory committee meeting in nine months on April 30, with ODAC voting 6-3 against AstraZeneca’s camizestrant for HER2-negative breast cancer and 7-1 in favor of Truqap for prostate cancer.
The camizestrant vote turned on a category error. Panelists fixated on the lack of overall survival benefit in the Phase 3 SERENA-6 trial, even though the trial wasn’t powered to detect OS with statistical significance. The actual question before the panel: whether progression-free survival at ESR1 mutation detection (before radiographic progression) is clinically meaningful. Acting ODAC chair Neil Vasan, director of breast cancer translational research at NYU Grossman School of Medicine, voted yes. Six others didn’t.
Truqap’s afternoon session was different. CAPItello-281 showed the AKT inhibitor plus abiraterone improved radiographic PFS in hormone-sensitive prostate cancer. A separate Phase 3 was terminated after an external data board found it unlikely to meet its dual primary endpoints of rPFS and overall survival, but seven panelists voted in favor regardless.
The bigger question is what one session actually changes. Arthur D. Little’s Rob Albarano called April 30 “a restart in a narrow sense” — the drivers of the nine-month adcomm slowdown haven’t disappeared, including leadership skepticism and a thin pool of independent outside experts.
CDER is on its fifth acting director in 16 months. Richard Pazdur left FDA in November 2025 just weeks after becoming its director. His absence was the most noticed thing in the room.
— Sarah Chen