Camizestrant

Camizestrant is an AstraZeneca PLC program in HR-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation detected during aromatase inhibitor and CDK4/6 inhibitor therapy, in combination with a CDK4/6 inhibitor (SERENA-6; approved as Etcamah). The FDA approved it on Sep 4, 2026. 1 FDA decision on record below. Every date links its source.

AZN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: AstraZeneca PLC (AZN). Decision record: 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, and the FDA extended the PDUFA goal date (announced 2026-05-27) without publicly disclosing the new date. The FDA granted accelerated approval on September 4, 2026, as Etcamah, in combination with a CDK4/6 inhibitor, with the Guardant360 CDx assay authorized as a companion diagnostic. Confirmatory studies are required. Also searched as Etcamah. Etcamah is the FDA-approved brand name for camizestrant (approved September 4, 2026). We track 1 catalyst event for this program: 0 upcoming and 1 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.

Catalyst history

Specialist biotech funds holding AZN, 13F for the quarter ended June 30, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is Camizestrant's next FDA decision or readout?

No upcoming catalyst is on our calendar for Camizestrant; 1 FDA decision is on record below.

What happened at Camizestrant's most recent FDA decision?

On Sep 4, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Camizestrant?

AstraZeneca PLC (AZN).

Has Camizestrant been approved by the FDA?

Yes. The FDA approved an application for Camizestrant on Sep 4, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.