Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex.

CHMP backed approval of an MAA from Bayer AG (Xetra:BAYN) for Vitrakvi larotrectinib to treat solid tumors with a NTRK gene fusion. If approved by the EC, Vitrakvi would become the first tissue-agnostic or "histology independent" drug marketed in the EU. The inhibitor of TrkA, TrkB and TrkC can be used to treat any type of non-hematological tumor so long as tumor NTRK fusion has been validated...