FDA grants accelerated approval to AstraZeneca's camizestrant combo

FREE Breaking News Alerts from StreetInsider.com!

E-mail Address

StreetInsider.com Top Tickers, 10/21/2026

1. SPCX
2. NVDA
3. NFLX
4. META
5. ISRG
6. TSLA
7. SMCI
8. RTX
9. S
10. COF

Go back to FDA grants accelerated approval to AstraZeneca's camizestrant combo

ETCAMAH® (camizestrant) in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer

September 4, 2026 7:03 PM EDT

Approval based on SERENA-6 Phase III trial results which showed combination reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumor mutation

Innovative treatment strategy has potential to reshape 1st-line treatment paradigm for patients in this setting

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZenecas ETCAMAH® (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast... More