Velcade filed with EMA for MCL-Janssen-Cilag

Janssen-Cilag has announced its submission of a type II variation to the European Medicines Agency (EMA) to expand the label for Velcade (bortezomib) to include its use, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated Mantle Cell Lymphoma (MCL). The submission is based on data from the landmark LYM-3002 trial in which significant benefits were seen when treating newly diagnosed patients with MCL using a Velcade-based combination, compared to a widely used standard of care. Patients in the study were previously untreated for their MCL and were either ineligible, or not considered, for a bone marrow transplant.

Compared to the treatment combination R-CHOP, the Velcade-based regimen, VR-CAP significantly improved progression-free survival (PFS) (the time patients live without their disease progressing) and showed improvements across a range of secondary endpoints. An independent review committee reported the increase in median PFS to be 59 percent (24.7 vs. 14.4 months), whereas the study investigators reported the increase in median PFS to be 96 percent (30.7 vs. 16.1 months. Overall, among patients receiving VR-CAP compared to R-CHOP in the LYM 3002 study, serious adverse events (AE) were reported in 38 percent vs. 30 percent of patients.