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# FDA Accepts Roche NDA for Breast Cancer Drug
- URL: https://www.fdaweb.com/fda-accepts-roche-nda-for-breast-cancer-drug/
- Published: 2026-06-03T12:00:00.000Z
- Updated: 2026-09-14T13:40:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161252

FDA has accepted for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy that could become the first selective estrogen receptor degrader (SERD) approved for use in patients with early-stage estrogen receptor-positive breast cancer. The filing seeks approval of giredestrant as an adjuvant treatment for adults with estrogen receptor (ER)-positive, HER2-negative stage I-III breast cancer. The agency has set a user fee review action target date of 11/30.

Roche says the application is supported by results from the Phase 3 lidERA Breast Cancer trial, which showed that giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard endocrine therapy. The study enrolled more than 4,100 patients with medium- or high-risk early-stage ER-positive, HER2-negative breast cancer.

At three years, 92.4% of patients treated with giredestrant remained alive and free of invasive disease, compared with 89.6% of patients receiving standard endocrine therapy, according to the company.

"Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest," said **Levi Garraway**, Roche's chief medical officer.

The company said the drug was generally well tolerated, with adverse events consistent with its known safety profile. Treatment discontinuation rates were lower with giredestrant than with standard endocrine therapy, at 5.3% and 8.2%, respectively.

Roche described giredestrant as an oral, next-generation SERD designed to block estrogen signaling by binding to and degrading the estrogen receptor, thereby inhibiting tumor growth. Unlike currently available injectable SERDs used primarily in advanced disease, giredestrant is administered orally and is being developed across multiple stages of breast cancer.