US Pharma MarketingRoche’s giredestrant secures FDA priority review for breast cancer
The US FDA has accepted priority review of the NDA for Roche’s investigational oral SERD, giredestrant, for breast cancer. 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. LOA and…
The US FDA has accepted priority review of the NDA for Roche’s investigational oral SERD, giredestrant, for breast cancer.
Source: Pharmaceutical Technology