EMA approves change to marketing authorization for Gilead's breast cancer drug Trodelvy
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Gilead Sciences (NASDAQ:GILD) on Tuesday said Europe's drug regulator had approved a change to its marketing authorization application for breast cancer treatment Trodelvy.
The European Medicines Agency (EMA) validated a Type II variation to GILD's marketing authorization application for Trodelvy.
A Type II variation is a major change to an authorization that may have a significant impact on the safety or efficacy of a medicine, but does not involve a change to the medicine's active substance or route of administration.
The variation was granted to Trodelvy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISHâ) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
The application was based on data from a late-stage study called TROPiCS-02, GILD said in a statement.
The variation for Trodelvy in this indication is also under review by the U.S. Food and Drug Administration, with the regulator set to decide on it by Feb. 2023.
Gilead (GILD) shares were largely unchanged at $85.87 in morning trade.