Velcade (bortezomib) for injection is indicated as monotherapy for use in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. The approval decision formally ratifies the Committee for Human Medicinal Products (CHMP) opinion made on March 16, 2005.
The second line approval is based on the results of the APEX trial, an international phase III study comparing Velcade against standard therapy high-dose dexamethasone in patients with relapsed multiple myeloma. The study demonstrated a significant survival advantage with Velcade in patients who had received one to three prior therapies. Importantly, this pronounced survival advantage was also observed in the second-line multiple myeloma patients where 55% fewer patients died in the Velcade arm relative to dexamethasone.
Velcade offers a completely novel approach to treating multiple myeloma, the second most common blood cancer, by acting on a unique target in cells called the proteasome. First approved in Europe on April 26, 2004 for the treatment of multiple myeloma patients who had received at least two prior therapies, Velcade was the first treatment in more than a decade to be approved for this group of patients.