FDA puts AstraZeneca’s camizestrant decision on hold after panel flags limited benefit

The FDA postponed its decision on AstraZeneca’s oral breast cancer drug camizestrant after an advisory committee voted (6-3) that the treatment did not show a clinically meaningful benefit in the Serena-6 switching trial. AstraZeneca provided additional analyses requested by the agency, including circulating tumor DNA data, and the FDA is reviewing them before issuing a ruling; no new decision date has been set. Europe has given a positive opinion for camizestrant, which will be marketed as Etcamah there.