Eisai gets new indication for Treakisym in Japan

Japanese pharma major Eisai (TYO: 4523) today said that the anticancer agent Treakisym (bendamustine hydrochloride) for Injection 100mg been approved in Japan for an additional indication of chronic lymphocytic leukemia.

Treakisym is the subject of a licensing agreement concluded between Eisai and Japanese specialty drug firm SymBio Pharmaceuticals (TYO: 4582).

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. Chronic lymphocytic leukemia is a blood cancer characterized by neoplastic transformation and excess propagation of lymphocytes, a type of white blood cell, in the bone marrow. With approximately 2,000 patients with chronic lymphocytic leukemia in Japan as well as an incidence rate of new cases of approximately 0.3 in 100,000, this is a disease with high unmet medical need. Furthermore, Treakisym has been designated as an orphan drug for chronic lymphocytic leukemia in Japan.

Bendamustine hydrochloride is an anticancer agent originally synthesized by German (formerly East German) pharmaceutical company Jenapharm and is marketed in Europe under the brand names Ribomustin and Levact as a treatment for non-Hodgkin's lymphoma.