BioCentury
ARTICLE | Clinical News

masitinib regulatory update

March 24, 2014 7:00 AM UTC

EMA's CHMP issued a negative opinion again recommending against conditional approval of masitinib from AB Science 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" (see BioCentury, Nov. 25, 2013). 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. ...