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# Genentech NDA for Breast Cancer Therapy
- URL: https://www.fdaweb.com/genentech-nda-for-breast-cancer-therapy/
- Published: 2026-02-20T12:00:00.000Z
- Updated: 2026-09-14T13:34:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160698

FDA has accepted for review a Genentech NDA for giredestrant, setting up a potential new treatment option for patients with endocrine-resistant breast cancer later this year. The company says it is seeking approval for the therapy’s use in combination with everolimus for adults with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer that has recurred or progressed following prior endocrine-based therapy. The agency has set a user fee review action target date of 12/18.

The filing is supported by data from the Phase 3 evERA Breast Cancer trial, which evaluated giredestrant plus everolimus against standard-of-care endocrine therapy plus everolimus in patients previously treated with a CDK4/6 inhibitor and endocrine therapy. According to the company, the combination reduced the risk of disease progression or death by 44% in the intention-to-treat population and by 62% in patients whose tumors harbored ESR1 mutations. In the ESR1-mutated subgroup, median progression-free survival was 9.99 months for patients receiving giredestrant compared with 5.45 months for those on comparator therapy.

Overall survival data remain immature, but interim analyses showed a positive trend in both the overall and ESR1-mutated populations, according to the company. Follow-up for survival will continue.

Adverse events were described as manageable and consistent with the known safety profiles of the individual agents. The company reported no unexpected safety signals, including no cases of photopsia.

Giredestrant is described as a next-generation, oral SERD designed to both block estrogen receptor signaling and induce receptor degradation, thereby inhibiting tumor cell proliferation. Unlike injectable SERDs, the drug is administered orally, a feature the company argues may reduce treatment burden.