Camizestrant is a AstraZeneca PLC program in 1st-line HR-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation, in combination with a CDK4/6 inhibitor (SERENA-6). It is under FDA review; the agency's action date has not been publicly disclosed. Every date links its source.
Indication under review: 1st-line HR-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation, in combination with a CDK4/6 inhibitor (SERENA-6). Sponsor: AstraZeneca PLC (AZN). Review status: NDA accepted July 2025 on the Phase 3 SERENA-6 trial; Breakthrough Therapy Designation May 2025. The Oncologic Drugs Advisory Committee voted 3-6 against on 2026-04-30; the FDA extended the PDUFA date (announced 2026-05-27) to review additional ctDNA-clearance analyses. The new action date has not been publicly disclosed. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
Camizestrant is under FDA review, but no action date has been publicly disclosed (PDUFA date extended 2026-05-27; new action date not public). The review status row below links the sponsor's own announcement; this page updates when a date becomes public.
No FDA decision for Camizestrant is in our archive yet.
In our records Camizestrant is under review or in development for 1st-line HR-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation, in combination with a CDK4/6 inhibitor (SERENA-6).
AstraZeneca PLC (AZN).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.