CHMP rejects Masiviera for Pancreatic Cancer- AB Science
The European Medicines Agency�s Committee for Medicinal Products for Human Use (CHMP) rejected AB Science�s application for an accelerated approval of Masiviera (masitinib)for treatment of Pancreatic Cancer , because of concerns about the drug�s efficacy, safety and quality. AB Science plans to appeal the decision and expects a second opinion from the committee this year.
The CHMP said that while the drug helped some patients in a trial, the study failed as a whole and any benefit to sub-groups would need to be confirmed.The committee also raised concerns about the increased toxicity of Masiviera when added to Gemzar from Eli Lilly, and about the company�s ability to control impurities in the drug.
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