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Camizestrant

All articles tagged with #camizestrant

health3 months ago•2 min saved

FDA puts AstraZeneca’s camizestrant decision on hold after panel flags limited benefit

The FDA postponed its decision on AstraZeneca’s oral breast cancer drug camizestrant after an advisory committee voted (6-3) that the treatment did not show a clinically meaningful benefit in the Serena-6 switching trial. AstraZeneca provided additional analyses requested by the agency, including circulating tumor DNA data, and the FDA is reviewing them before issuing a ruling; no new decision date has been set. Europe has given a positive opinion for camizestrant, which will be marketed as Etcamah there.

via Fierce Biotech|

#astrazeneca #breast-cancer #camizestrant

business3 months ago•2 min saved

AstraZeneca stock slides after FDA advisory panel rejects camizestrant

An FDA advisory panel voted 6-3 against approving AstraZeneca's oral breast cancer drug camizestrant due to concerns about trial design, sending AstraZeneca shares about 2% lower in London. While the panel did not question the drug's safety, it said the SERENA-6 results did not prove that early switching to camizestrant improves long-term survival. The company will continue working with the FDA as it reviews the application, and analysts say the setback may be more sentiment-related than a fundamental issue for the stock.

via CNBC|

#astrazeneca #breast-cancer #business

health3 months ago•5 min saved

FDA panel rebuffs AstraZeneca's early ESR1-driven camizestrant approach in breast cancer

An FDA advisory panel voted 6-3 against approving AstraZeneca's oral SERD camizestrant for HR-positive, HER2-negative metastatic breast cancer with ESR1 mutations detected before progression, citing insufficient evidence of a meaningful long-term benefit and trial-design concerns (no crossover, OS data immature). Approval now seems unlikely despite a progression-free survival improvement seen in Serena-6.

via Fierce Biotech|

#astrazeneca #breast-cancer #camizestrant