Janssen seeks expanded approval of VELCADE from EU for Mantle Cell Lymphoma

Janssen-Cilag International NV today 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). MCL is a rare and aggressive blood cancer that usually occurs in older adults. VELCADE, in combination with other agents, is currently licensed to treat patients with Multiple Myeloma who have not yet had therapy or whose cancer has begun to progress after treatment.

"We are committed to developing and delivering innovative therapeutic solutions to treat serious diseases," said Jane Griffiths, Company Group Chairman, Janssen Europe, the Middle East and Africa (EMEA). "The encouraging data we have seen on VELCADE when used as part of frontline treatment of Mantle Cell Lymphoma reinforce our belief that this therapy has the potential to be an important option in the treatment of this cancer."

Today's submission is based on data from the landmark LYM-3002 trial. In results from this study, presented at the 50^th Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 19^th Annual Congress of the European Hematology Association (EHA), 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; HR 0.63; p<0.001), whereas the study investigators reported the increase in median PFS to be 96 percent (30.7 vs. 16.1 months; HR 0.51; p<0.001).

VR-CAP was associated with additional, but manageable, toxicity as compared to R-CHOP. Higher rates of thrombocytopenia and infection were observed with VR-CAP. However, there were no differences observed in bleeding events between the two treatment groups and rates of peripheral neuropathy were similar. 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 and grade ≥3 AEs were reported in 93 percent vs. 85 percent. Discontinuations of treatment due to AEs were nine percent (VR-CAP) vs. seven percent (R-CHOP) and on-treatment drug-related deaths were two percent vs. three percent.