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CHMP confirms negative opinion for masitinib for GIST

March 22, 2014 12:54 AM UTC

AB Science S.A. (Euronext:AB) fell EUR 1.61 (11%) to EUR 12.67 on Friday after EMA's CHMP issued a negative opinion again recommending against conditional approval of masitinib for second-line treatment of gastrointestinal stromal tumors (GIST). AB Science was appealing a November negative opinion from CHMP. The committee said it still had "major concerns" about masitinib's benefits and said there were "outstanding problems related to quality control during its manufacture," though CHMP said masitinib's safety was "of less concern." AB Science said it now plans to submit U.S. and EU regulatory applications seeking full approval in the indication in 2017 based on data from an ongoing Phase III trial; data are expected in late 2016 or early 2017 (see BioCentury Extra, Nov. 22, 2013). ...