Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), announced on Friday that the US Food and Drug Administration (FDA) has accepted its New Drug Application for investigational oral giredestrant plus everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer after prior endocrine therapy.

The agency set a Prescription Drug User Fee Act action date of 18 December 2026. The combined regimen could become the first oral selective oestrogen receptor degrader combination approved in the post-CDK4/6 inhibitor setting.

Acceptance of the filing is supported by Phase III evERA results showing the combination reduced risk of disease progression or death by 44% in the intention-to-treat (ITT) population and 62% in ESR1-mutated patients versus standard endocrine therapy plus everolimus.