Europeans Give Positive Opinion for Velcade Against Mantle Cell Lymphoma

The Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion on the use of Bortezomib (Velcade) in mantle cell lymphoma (MCL).

Previously, Velcade was only approved by the regulatory agency for the treatment of multiple myeloma.

This new indication covers the use of bortezomib, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), for the treatment of adult patients with previously untreated MCL who are unsuitable for hematopoietic stem cell transplantation.

Velcade was recently approved by the US FDA for the same indication.

The agency's positive opinion is based on data from the phase 3 study, LYM-3002, conducted in 487 patients with newly diagnosed MCL who were ineligible for bone marrow transplant, which was presented at the 2014 American Society of Clinical Oncology annual meeting (J Clin Oncol. 2014;32[15 Suppl]:8500).

Patients were randomized to receive one of two drug combinations: either the widely used standard of care combination containing rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); or the new combination containing bortezomib, rituximab, cyclophosphamide, doxorubicin (Adriamycin), and prednisone (VR-CAP).

The results show that the VR-CAP regimen significantly improved progression-free survival, among other end points.

An independent review committee reported the increase in progression-free survival to be 59% (median, 24.7 vs 14.4 months; hazard ratio [HR], 0.63; P < .001), whereas the study investigators reported the increase in progression-free survival to be 96% (median, 30.7 vs 16.1 months; HR, 0.51; P < .001).

Bortezomib was associated with additional, but manageable, toxicity when compared with the standard regimen, the manufacturer notes.

SourceL Medscape