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Lilly lymphoma drug designated orphan status

Eli Lilly has reported that the European Medicines Agency has granted its investigational cancer agent enzastaurin orphan drug designation for the treatment of diffuse large B-cell lymphoma.

Although rare, diffuse large B-cell lymphoma (DLBCL) is the most common sub-type of non-Hodgkin's lymphoma (NHL).

Enrolment into a phase III trial studying enzastaurin is currently underway. The trial is a 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 primary endpoint of the study will be overall disease-free survival.

“In recent years, there has been progress in improving first-line therapies that help more patients achieve remission. However, our objective with enzastaurin is to develop an agent that may fill this important therapeutic need – the ability to keep DLBCL patients in remission,” said Richard Gaynor, vice president, cancer research and global oncology platform leader for Eli Lilly.

Enzastaurin is an oral, serine threonine kinase inhibitor which selectively targets the PKCBeta and PI3/AKTsignaling pathways. By blocking these key pathways frequently over-expressed in a wide variety of cancers, enzastaurin suppresses tumor cell proliferation, induces tumor cell death and inhibits tumor-induced angiogenesis.