AB Science SA announces CHMP negative opinion on appeal for conditional authorization of Masitinib in second-line treatment of GIST


Thursday, 20 Mar 2014 02:40pm EDT 

AB Science SA:Announces Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) has adopted negative opinion on conditional marketing authorization for Masican (Masitinib mesylate) for treatment of malignant gastrointestinal stromal tumor (GIST) resistant to first-line treatment.Decision is on appeal filed by AB Science following previous negative opinion adopted by the CHMP in Nov. 2013.CHMP considered that study did not provide enough evidence to be confident that overall survival benefit was robust and that safety profile was sufficiently characterized.AB Science intends to file for marketing authorization with data from phase 3 confirmatory study that is currently recruiting patients in second-line treatment of GIST.