CHMP’s July opinions include denial of Mirati’s adagrasib
EMA committee recommends approval of Talvey, Tepkinly and Tevimbra, label expansions for seven drugs
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). ...