USFDAMay 27, 2026, 06:08 AM
AstraZeneca: US FDA Extends Camizestrant Decision Date
AI Summary
The US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for AstraZeneca's camizestrant, an investigational treatment for HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation. The extension is to allow review of additional data requested by the FDA, following a non-majority vote from the Oncologic Drugs Advisory Committee in April 2026. AstraZeneca has provided new analyses, including ctDNA clearance data, which will be presented at ASCO 2026. Separately, the European Medicines Agency adopted a positive opinion for camizestrant on May 22, 2026, and the drug is already approved in UAE and Saudi Arabia.
Key Highlights
- US FDA extended the PDUFA date for camizestrant's New Drug Application (NDA).
- Extension is for camizestrant in combination with CDK4/6 inhibitors for 1st-line HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation.
- FDA requested additional data, including ctDNA clearance data, to support the application.
- FDA's Oncologic Drugs Advisory Committee did not reach a majority vote in April 2026.
- European Medicines Agency adopted a positive opinion for camizestrant on May 22, 2026.
- Camizestrant is already approved in the United Arab Emirates and Saudi Arabia.
- The NDA is based on positive results from the pivotal SERENA-6 Phase III trial.
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