CHMP rebuffs AB Science's masitinib for GIST
AB Science S.A. (Euronext:AB) fell EUR 4 (21%) to EUR 15 on Friday after EMA's CHMP issued a negative opinion recommending against approval of an MAA from the company for Masican masitinib to treat gastrointestinal stromal tumors (GIST) that cannot be removed surgically or have progressed following treatment with Gleevec imatinib. The MAA was based on data from a Phase II trial showing that second-line treatment with masitinib significantly improved median overall survival (OS) vs. Sutent sunitinib at a median follow-up of 14 months in GIST patients whose disease progressed following treatment with Gleevec.
CHMP said it was "difficult to interpret" the results of the trial, which the committee said was exploratory and not designed to compare masitinib to Sutent. CHMP also said it was concerned that safety data for the proposed dose of masitinib were only available for a few patients and about the quality control of masitinib during the manufacturing process. The stem cell factor ( SCF) receptor tyrosine kinase (c-Kit; KIT; CD117) inhibitor is also under EMA review for pancreatic cancer. ...