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(Reuters) -Gilead Sciences Inc said on Friday the U.S. Food and Drug Administration had greenlighted expanded use of Trodelvy to treat the most common.
Bumper December meeting sees CHMP recommend 15 new medicines
14th December 2020
The European Medicines Agency’s (EMA) committee for Medicinal Products for Human Use (CHMP) recommended 15 new medicines for approval in its final meeting of the year.
First to score a recommendation was AstraZeneca/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer, following an accelerated review of the anti-HER2 therapy.
The CHMP also recommended Dynavax’s Heplisav (hepatitis B surface antigen) for active immunisation against hepatitis B virus infection and ViiV Healthcare’s Rukobia (fostemsavir) for the treatment of multidrug resistant HIV-1 infection.
Up next, the CHMP adopted a positive opinion for Bristol Myers Squibb’s Inrebic (fedratinib) for the treatment of primary myelofibrosis and myelofibrosis secondary to polycythaemia vera, as well as essential thrombocythaemia.