Latest batch of EMA/CHMP drug approval recommendations

15 October 2021

Following its meetings over October 11-14, the European Medicines Agency’s human medicines committee, the CHMP, today recommended five novel medicines and one generic for approval.

The final European Commission decisions on the Marketing Authorization Application for the various drugs is anticipated later in 2021.

US biotech firm Gilead Sciences’ (Nasdaq: GILD) Trodelvy (sacituzumab govitecan) was granted a positive opinion for the treatment of unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease.

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