LOGO
LOGO

FDA Calendar - AstraZeneca PLC

Company Name AstraZeneca PLC
AZN, AZN.L, ZEG.DE, AZN.ST
Drug Name Camizestrant (NDA)
Event Name FDA panel to review Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy whose tumours express ESR1 gene mutations
Event Date 04/30/2026
Outcome Date 04/30/2026
Outcome FDA panel voted against recommending approval of Camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer on Apr.30, 2026
Drug Status
Rival Drugs ORSERDU, developed by Stemline Therapeutics; Lilly's Inluriyo
Market Potential Analysts estimate peak sales for Camizestrant to range between $1.5 billion and $3 billion.
Other Approvals
News