Eisai Gets Approval In Japan For Anti-cancer AgentBy
Eisai has received approval in Japan for an additional indication of its anti-cancer agent, Treakisym (bendamustine hydrochloride) for injection 100 mg, in chronic lymphocytic leukemia. Treakisym is the subject of a licensing agreement between Eisai and SymBio Pharmaceuticals, based in Tokyo.
Treakisym was initially approved in Japan in October 2010 for relapsed or refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma. Under the licensing agreement concluded between the two companies, Eisai has been marketing the product in Japan since its launch in December 2010.
Symbio filed an application for this additional indication in December 2015 in response to a development request from the Japanese Ministry of Health, Labor and Welfare’s Study Group on Unapproved and Off Label Drugs with high unmet medical needs. Treakisym has also been designated as an orphan drug for chronic lymphocytic leukemia in Japan.