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AB Science SA Announces Negative Opinion from CHMP for Masitinib in Second-Line Treatment of Gastro-Intestinal Stromal Tumor


Thursday, 21 Nov 2013 02:31pm EST 

AB Science SA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has adopted a first negative opinion for Masican (Masitinib mesylate) for the treatment of malignant gastrointestinal stromal tumor (GIST) resistant to first line treatment. The CHMP mentions three concerns that create uncertainties which are the exploratory nature of the study making it difficult to interpret the survival benefit, the limited sample size for safety and the uncertainties on impurities in manufacturing. AB Science SA will appeal this decision and continue to work with CHMP to address pending concerns to reach positive consensus for second opinion.