Injection strength Velcade shown effective against hematological cancers

01-22-2007

Millennium Pharmaceuticals, Inc. (MLNM) announced the publication of clinical data of Velcade in the treatment of newly diagnosed multiple myeloma (MM), MM accompanied by advanced renal failure, and mantle cell lymphoma (MCL). These data underscore the substantial activity and well-characterized safety profile of Velcade in the treatment of hematological cancers.

In Haematologica Journal, results of a Phase II study showed a complete response and near complete response (nCR) rate of 21% after four cycles of induction therapy with Velcade plus dexamethasone. Along with a previously published study by Sundar Jagannath, MD, of St. Vincent's Comprehensive Cancer Center, these data are among the highest recorded CR/nCR rates for a dexamethasone-based therapy in the treatment of front-line multiple myeloma. In previous clinical trials, Velcade in combination with other commonly used therapies has shown an overall response rate of up to 95% and a CR/nCR rate of up to 43% in the front-line MM setting.

The open-label, multicenter study conducted by Intergroupe Francophone du Myelome (IFM) investigated the efficacy and safety of Velcade in combination with dexamethasone as induction therapy prior to stem cell transplantation in 48 evaluable patients with newly diagnosed MM eligible for stem cell transplantation. In the 42 patients who went on to stem cell collection, all patients were able to proceed to transplant. Therapy was well tolerated. The most common side effects were gastrointestinal symptoms, peripheral neuropathy and fatigue.

A Phase III registration-enabling study of Velcade in combination with dexamethasone compared to vincristine, doxorubicin, and dexamethasone (VAD), a conventional induction therapy, is ongoing.

In the Blood First Edition Paper, results of a retrospective analysis evaluating VELCADE therapies in relapsed and / or refractory MM patients with advanced renal failure demonstrated an ORR of 75% a CR/nCR rate of 30%.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2007, Biotech Business Week via NewsRx.com.