Masican masitinib: Phase III ongoing

An independent DSMB recommended continuation of a double-blind, placebo-controlled, international Phase III trial evaluating 6 mg/kg/day masitinib based on safety and efficacy data. The trial is enrolling about 150 adult mastocytosis patients with severe handicaps/symptoms. A DSMB previously recommended continuation last November based on a futility analysis. The final analysis of data is expected next year. Masitinib has Orphan Drug designation for the indication in the U.S. and EU.

EMA's CHMP recommended against approval of masitinib for first-line treatment of non-resectable locally advanced or metastatic pancreatic cancer in combination with gemcitabine and for second-line treatment of gastrointestinal stromal tumors (GIST) that cannot be removed surgically or has progressed following treatment with imatinib (see BioCentury, March 24 & May 26). ...