Millennium Pharma has submitted a supplemental new drug application (sNDA) with the FDA for Velcade. The drug, which is being co-developed by Millennium and Johnson & Johnson Pharmaceutical, is intended for the treatment of relapsed or refractory mantle cell lymphoma or MCL, a type of cancer that is not curable. MCL is a subtype of the most common hematological cancer, non-Hodgkin's lymphoma or NHL.
The sNDA filing is based on final data from a large multicenter Phase II study, named PINNACLE trial. The study demonstrated an overall response rate of 33 percent, and a complete response rate of 8 percent.