AB Science S.A. (Euronext:AB) fell EUR 2.95 (21%) to EUR 11.36 on Friday after EMA's CHMP recommended against approval of the company's Masiviera masitinib for first-line treatment of non-resectable locally advanced or metastatic pancreatic cancer in combination with gemcitabine. According to CHMP, masitinib was not effective in the overall group of pancreatic cancer patients. The committee also was concerned with the increased toxicity of masitinib and with impurities and the quality of potential commercial batches of the stem cell factor (SCF) receptor tyrosine kinase (c-Kit; KIT; CD117) inhibitor. AB Science said it plans to appeal the decision.
The company already requested a reexamination of a November opinion from CHMP recommending against approval of masitinib for gastrointestinal stromal tumors (GIST) that cannot be removed surgically or has progressed following treatment with imatinib
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