Why did the FDA delay its decision on AstraZeneca’s oral SERD camizestrant?

The FDA postponed its ruling on AstraZeneca’s camizestrant after an advisory committee voted that the Serena‑6 trial failed to show a clinically meaningful benefit. Regulators want to review additional analyses, including ctDNA clearance data, before deciding, reflecting a broader shift toward stricter evidentiary standards for oncology drug approvals.