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AB Science SA announces negative opinion from CHMP for the conditional approval of Masitinib in the treatment of pancreatic cancer

Thursday, 23 Jan 2014 12:13pm EST 

AB Science SA:Says the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has adopted a negative opinion for the conditional approval of Masiviera (Masitinib mesylate) for the first-line treatment of non-resectable locally advanced or metastatic pancreatic cancer.Says the CHMP mentions three concerns.Says the CHMP's first concern is the failure of the study in the overall population and the need to confirm the benefit in the subgroups since according to CHMP the study was not designed to show benefit in these smaller groups.Says the CHMP's second concern is the increased toxicity of the combination of masitinib and gemcitabine as compared to gemcitabine alone.Says the CHMP also has concerns about the quality of the product, and in particular that patient exposure to impurities is insufficiently controlled and that the reproducibility between clinical and commercial batches cannot be guaranteed.Says it intends to appeal.Says first reason for the appeal is that the two subgroups where masitinib is efficient, patients with pain and patients with aggressive genomic biomarker represent an urgent need since the median survival is shorter than in the overall population.Says the second reason is that the findings in the two subgroups are consistent with the known action of masitinib able to boost and modulate the innate immune system.Says the appeal should lead the CHMP to deliver a second opinion in the course of 2014.