A decision from the FDA is anticipated by 30 November 2026.
The filing acceptance is based on Phase III data from the lidERA Breast Cancer study. Credit: Arif biswas / Shutterstock.com.
The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational oral selective oestrogen receptor degrader (SERD), giredestrant, for breast cancer.
The application seeks approval of giredestrant as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I to III breast cancer. Discover B2B Marketing That Performs
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