SNDA filed for bortezomib compound for injection in treating relapsed mantle cell lymphoma

07-11-2006

Millennium Pharmaceuticals, Inc. (MLNM) announced the company has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for Velcade in the treatment of relapsed or refractory mantle cell lymphoma (MCL), an aggressive subtype of non-Hodgkin lymphoma (NHL) that is not curable.

The filing is based on final data from the phase 2 PINNACLE trial, one of the largest multicenter studies in relapsed MCL to date, which showed a 33% overall response rate and an 8% complete response rate. The median duration of response was 9.2 months; 13.5 months in patients achieving a complete response. These results are similar to four other phase 2 clinical trials that recorded overall response rates of 30 to 40% with single-agent Velcade.

Currently, Velcade has been approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy. To date, over 33,000 multiple myeloma patients have been treated with Velcade worldwide. Earlier this year, Millennium and co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), initiated a phase 3 clinical trial with Velcade in combination with rituximab in patients with relapsed or refractory follicular lymphoma.

Treatment was well tolerated. The most common nonhematologic adverse events were fatigue, gastrointestinal events and peripheral neuropathy. Hematologic toxicities were consistent with those previously seen with Velcade.

Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of Velcade in the U.S.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. Velcade is approved in more than 65 countries worldwide and is approved in the European Union at first relapse.

Millennium Pharmaceuticals's research and development are focused in two therapeutic areas: oncology and inflammation.

This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2006, Pain & Central Nervous System Week via NewsRx.com.