Velcade for injection extends survival rate
Millennium Pharmaceuticals has announced that in the final survival endpoint analysis in the phase III confirmatory Apex study comparing patients receiving Velcade (bortezomib) to those receiving high-dose dexamethasone, Velcade produced a statistically significant survival benefit.
Millennium Pharmaceuticals has announced that in the final survival endpoint analysis in the phase III confirmatory Apex study comparing patients receiving Velcade (bortezomib) to those receiving high-dose dexamethasone, Velcade produced a statistically significant survival benefit.
The study was designed to include survival as a secondary endpoint and allowed crossover for patients experiencing disease progression on high-dose dexamethasone to receive Velcade. 'We are extremely pleased and enthusiastic about the clear survival advantage demonstrated in this trial,' said Dr David Schenkein, vice president, clinical oncology development, Millennium. 'This is the first randomised study of a treatment in the relapsed multiple myeloma setting to show a survival advantage over a current standard of care. Further, these data potentially represent a significant opportunity to make an important difference in extending survival for patients living with multiple myeloma.'
About bortezomib for injection
Velcade, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma, a cancer of the blood. Millennium received approval from the FDA on May 13, 2003 to market Velcade for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of Velcade is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival. On April, 27, 2004, the European Commission granted marketing authorization for Velcade for the treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on their last therapy. It is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development; Millennium is responsible for commercialisation of the product in the US; Ortho Biotech and Janssen-Cilag will be responsible for Europe and the rest of the world, except Japan where Janssen Pharmaceutical K.K. will be responsible