FDA APPROVES MILLENNIUM'S VELCADE FOR MCL

Millennium Pharmaceuticals announced that the FDA has approved Velcade for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. MCL is a relatively uncommon and aggressive form of non-Hodgkin's lymphoma for which there was no standard of care in the relapsed or refractory setting. Velcade is already approved for treating multiple myeloma patients who have received one prior therapy.

The approval is based on data from the PINNACLE trial, the largest study to date in patients with MCL, according to the company. PINNACLE was a prospective, multicenter, single-arm, open-label study in patients with MCL whose disease progressed following at least one prior therapy. Response rates to VELCADE were determined according to the International Workshop Response Criteria and based on independent radiologic review of computerized tomography scans. The overall response rate was 31 percent.

Earlier this year, Millennium and Johnson & Johnson Pharmaceutical R&D initiated an international Phase III clinical trial with Velcade in combination with rituximab in patients with relapsed or refractory follicular lymphoma, another subtype of non-Hodgkin's lymphoma. Additionally, more than 170 company-sponsored and investigator-initiated trials of Velcade are ongoing in various disease settings.