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CHMP’s July opinions include denial of Mirati’s adagrasib
EMA committee recommends approval of Talvey, Tepkinly and Tevimbra, label expansions for seven drugs
July 22, 2023 1:10 AM UTC
Updated on Jul 26, 2023 at 6:31 PM UTC
Highlights from this month’s meeting of EMA’s CHMP include approval recommendations for 10 new medicines and label extensions for seven others, while the agency issued a negative opinion on Mirati’s RAS GTPase inhibitor.
Six of the new therapies recommended for approval are cancer treatments, including PD-1 mAb Tevimbra tislelizumab from Novartis AG (SIX:NOVN; NYSE:NVS) and two bispecific antibodies: CD3 and GPRC5D-targeting Talvey talquetamab from the Janssen Pharmaceuticals unit of Johnson & Johnson (NYSE:JNJ) and CD3 X CD20 bispecific Tepkinly epcoritamab from AbbVie Inc. (NYSE:ABBV). ...