Eli Lilly's Lymphoma Drug Granted Orphan Drug Status in Europe

Eli Lilly announced that the European Medicines Agency (EMEA) has granted orphan drug designation to enzastaurin, its investigational, multitargeted, oral cancer agent, for the treatment of diffuse large B-cell lymphoma (DLBCL). Although rare, DLBCL is the most common subtype of non-Hodgkin's lymphoma.

Enrollment into a Phase III clinical trial studying enzastaurin is currently underway. The PRELUDE trial is a randomized, placebo-controlled study 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 disease relapse. The study will compare the efficacy, safety and tolerability of enzastaurin, taken orally for up to three years, versus placebo. The study is expected to enroll 459 patients at 100 sites worldwide. The primary endpoint of the study will be overall disease-free survival.

Enzastaurin is an oral, serine threonine kinase inhibitor that selectively targets the PKCBeta and PI3/AKTsignaling pathways. By blocking these key pathways frequently overexpressed in a wide variety of cancers, enzastaurin suppresses tumor cell proliferation, induces tumor cell death and inhibits tumor-induced angiogenesis. In addition to DLBCL, enzastaurin is also being studied in other tumor types including breast, colon, lung, ovarian and prostate cancers.