Shots:
- The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy
- NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or death by 44% in the ITT population (HR=0.56) and 62% in the ESR1-mutated population (HR=0.38) vs SoC endocrine therapy + everolimus; median PFS was 9.99 vs 5.45mos respectively
- The US FDA has set a PDUFA date of 18 Dec 2026; if approved, the regimen could become the first oral SERD combination in the post-CDK4/6 inhibitor setting
Ref: Roche | Image: Roche | Press Release
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