Eli Lilly announced that the European Medicines Agency ( EMEA ) has granted Enzastaurin, an investigational, multi-targeted, oral, cancer agent, orphan drug designation for the treatment of diffuse large B-cell lymphoma ( DLBCL ).

Although rare, diffuse large B-cell lymphoma is the most common sub-type of non-Hodgkin's lymphoma ( NHL ) of which approximately 50% of high-risk patients relapse within three years after receiving first line therapy.

Enzastaurin is an oral, serine threonine kinase inhibitor which selectively targets the PKCBeta and PI3/AKT signaling 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.

Enzastaurin administration is associated with fatigue, diarrhea, nausea, decreased platelets, cough, vomiting, transaminase elevation, dyspnea, peripheral edema, and dizziness.

In addition to diffuse large B-cell lymphoma, Enzastaurin is also being studied in other tumor types including breast, colon, lung, ovarian and prostate cancers.

Enrollment into a Phase III clinical trial studying Enzastaurin on patients with diffuse large B-cell lymphoma, is currently underway.
The PRELUDE ( Preventing Relapse in Lymphoma Using Daily Enzastaurin ) 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 across 100 sites worldwide.
The primary endpoint of the study will be overall disease-free survival.

Source: Eli Lilly, 2007


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