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AB Science announces negative opinion from CHMP on appeal for conditional authorization of Masitinib in pancreatic cancer


Thursday, 22 May 2014 02:04pm EDT 

AB Science SA:Says Committee for Medicinal Products for Human Use (CHMP) of European Medicine Agency (EMA) has adopted negative opinion on conditional marketing authorization for Masiviera (Masitinib mesylate) for first line treatment of non resectable locally advanced or metastatic pancreatic cancer.This decision is on appeal filed by AB Science following previous negative opinion adopted by the CHMP in January.Rapporteurs considered that evidence presented in pain and in genetic subgroups were promising, but that benefit was not sufficiently demonstrated since data were derived from subgroup analysis.Safety profile of masitinib did not raise serious issues in consideration of other more toxic alternatives used in pancreatic cancer.Majority of outstanding quality issues were resolved.However, in the absence of demonstrated benefit, CHMP considered that benefits of masitinib did not outweigh its risks at this stage of the development of masitinib.Phase 3 confirmatory study will be necessary to clearly demonstrate benefit of masitinib in target subgroups, which account for about 60 pct of pancreatic cancer patients.