Shots:
- The US FDA has accepted NDA & granted priority review to Genentech’s giredestrant as an adj. treatment for adults with ER+, HER2-, ESR1-mutated stage I, II, and III breast cancer (PDUFA: Nov 30, 2026)
- NDA was supported by the P-III (lidERA Breast Cancer) trial (n>4,100), where adj. giredestrant reduced iDFS by 30%, with 92.4% vs 89.6% pts alive & free of invasive disease at 3yrs., plus OS data showed a favorable trend & is under evaluation; iDFS benefit was consistent across all relevant subgroups
- Also, the FDA accepted the NDA for giredestrant plus everolimus in ESR1-mutated, ER-positive advanced breast cancer based on the evERA trial, with a decision expected in Dec 2026
Ref: Businesswire | Image: Genentech |Press Release
Related News: Roche Reports P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer
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