Treanda bendamustine regulatory update

SymBio and partner Eisai said Japan's Ministry of Health, Labor and Welfare (MHLW) lifted a postmarketing surveillance requirement for Treakisym bendamustine, which is approved to treat refractory/relapsed low-grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma (MCL). Based on safety data from 583 patients and efficacy data from 497 patients submitted to the agency, MHLW concluded that postmarketing surveillance had been properly conducted with necessary measures for proper use and that no further surveillance is required. MHLW approved Treakisym in 2010 with the requirement due to a "very limited" number of subjects treated in domestic trials. ...