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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
Return to FDA Calendar
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