US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data

https://www.astrazeneca.com/media-centre/press-releases/2026/us-fda-decision-date-camizestrant-extended.html?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz--TO9rHilB0PJ0Ul9jc-LZtbCbZMHt4OB414_MzUu1l5lN88Dgpwuu6mE2-6VcdNNgaXAb0Rfx0g8uh3RsJLmHDP4PyGg&_hsmi=420814327&utm_content=420814327&utm_source=hs_email The FDA has pushed back the decision date for AstraZeneca's experimental breast cancer drug camizestrant, following a negative vote from a group of agency advisers, the company said. The extra time will allow the FDA to review additional analyses that AstraZeneca is providing. FDA advisers took issue with the study design of the pivotal SERENA-6 trial, though European regulators have recommended the drug be approved. AstraZeneca did not specify the new target date for an FDA decision.