Lilly's enzastaurin gets EMEA orphan status for DLBCL

US drug major Eli Lilly says that the European Medicines Agency (EMEA) has granted enzastaurin, its investigational, multi-targeted, oral cancer drug, Orphan Drug status for the treatment of diffuse large B-cell lymphoma (DLBCL). Although rare, DLBCL is the most common sub-type of non-Hodgkin's lymphoma (NHL) of which approximately 50% of high-risk patients (high-risk is defined as having an International Prognostic Index score of 3-5) relapse within three years after receiving first-line therapy.

Enrollment into a Phase III clinical trial studying enzastaurin is currently underway. The PRELUDE study is a randomized, placebo-controlled evaluation in DLBCL patients at high risk for relapse who have achieved remission following first-line therapy. Specifically, enzastaurin is being investigated as a maintenance therapy to prevent relapse. The study will compare the efficacy, safety and tolerability of enzastaurin, taken orally for up to three years, versus placebo.