Posted by Michael Wonder on 21 Feb 2026
FDA accepts new drug application for Roche’s giredestrant in ESR1 mutated, ER positive advanced breast cancer
20 February 2026 - Roche announced today that the US FDA has accepted the company’s new drug application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor positive, human epidermal growth factor receptor 2 negative, ESR1 mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen.
The FDA is expected to make a decision on the approval by 18 December 2026.
