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Oral Serd

All articles tagged with #oral serd

health4 hours ago•5 min saved

Roche bets on adjuvant promise after giredestrant’s first-line miss

Roche’s oral SERD giredestrant failed to achieve statistical significance in the persevERA first-line trial for HR+/HER2- metastatic breast cancer when combined with palbociclib, but the company remains optimistic about its adjuvant potential and is designing a new CDK4/6–giredestrant study for early-stage disease. Earlier lidERA showed an adjuvant iDFS benefit; OS data are immature. Roche is pursuing ESR1-mutant labeling in second-line work and exploring additional adjuvant combos, with an FDA decision target around late 2026.

via Fierce Biotech|

#adjuvant #breast-cancer #giredestrant

health6 days 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