Posted by Michael Wonder on 02 Jun 2026
FDA accepts new drug application for Roche’s giredestrant in oestrogen receptor positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting
2 June 2026 - Roche announced today that the US FDA has accepted the company’s new drug application under priority review for giredestrant, an investigational oral selective oestrogen receptor degrader, as an adjuvant treatment for adults with oestrogen receptor positive, human epidermal growth factor receptor 2 negative, stage I, II, and III breast cancer.
The FDA is expected to make a decision on the approval by 30 November 2026.
