Janssen seeks expanded EU VELCADE approval for Mantle Cell Lymphoma -
Janssen-Cilag International NV today announced its submission of a variation type II to the European medicines Agency (EMA) to extend the label for VELCADE® (bortezomib) to include its use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of previously untreated adult patients Mantle Cell Lymphoma (MCL). MCL is an aggressive cancer of the blood that rare and usually occurs in older adults. VELCADE in combination with other agents, is currently approved to treat multiple myeloma that has not yet received any treatment or whose cancer started to progress after treatment.
"We are committed to develop and provide innovative therapeutic solutions to treat serious diseases," said Jane Griffiths, Group Company Chairman, Janssen Europe, Middle East and Africa (EMEA). "The encouraging data we have seen on VELCADE when used as part of a first-line mantle cell lymphoma reinforce our belief that this therapy has the potential to be an important option in the treatment of this cancer. "
Communication today is based on data from the LYM-3002 trial landmark. in the results of this study, presented at the 50 e annual Meeting of the American Society of Clinical Oncology (ASCO) and the 19 e annual Congress of the European Hematology Association (EHA), significant benefits were observed when treating patients with newly diagnosed MCL using a combination of VELCADE based , compared to a widely used standard of care. Patients in the study were not previously treated for MCL and were not eligible or not considered for a bone marrow transplant. Compared to the combination treatment R-CHOP, the treatment with VELCADE, significantly improves progression-free survival VR-CAP (PFS) (the time patients live without disease progression) and showed through improvements range of secondary endpoints. An independent review committee reported increased median PFS to 59 percent (24.7 vs 14.4 months; HR 0.63; p <0.001), while the study researchers reported the increased median PFS to 96 percent (30.7 vs 16.1 months; HR 0.51 ;. p <0.001)
VR-CAP has been associated with most, but manageable, toxicity with respect to R-CHOP. Higher rates of thrombocytopenia and infection were observed with VR-CAP. However, there were no observed differences in events between the two treatment groups and peripheral neuropathy bleeding rates were similar. Overall, patients receiving VR-CAP compared with R-CHOP in 3002 LYM study, serious adverse events (AE) were reported in 38 percent against 30 percent of patients and grade ≥3 AEs were reported in 93 percent against 85 percent. Treatment discontinuations due to AEs were nine percent (VR-CAP) versus seven percent (R-CHOP), and on the treatment of drug-related deaths were two percent against three percent.
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