EU approves Velcade for MCL - Janssen-Cilag

Janssen-Cilag announced that the European Commission has approved a variation to the terms of the marketing authorisation of Velcade (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated Mantle Cell Lymphoma (MCL) who are unsuitable for blood stem-cell transplantation.

The approval is based on data from the Phase III study, LYM-3002, a randomised, open-label, active-controlled, multicentre, international, prospective study including 487 patients with newly diagnosed MCL who were ineligible, or not considered, for bone marrow transplantation. The results showed significant benefits when treating patients with MCL using a Velcade-based combination (VR-CAP[*]), compared to a widely used standard of care combination (R-CHOP[†]) that did not include Velcade. The VR-CAP regimen significantly improved progression-free survival (PFS), the primary endpoint, and showed improvements across a range of secondary endpoints. An independent review committee reported the increase in PFS to be 59 percent (median 24.7 vs. 14.4 months), whereas the study investigators reported the increase in PFS to be 96 percent (median 30.7 vs. 16.1 months). VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP.

Comment: Velcade comes off patent in the US in 2017, and 2019 in the EU. This is the earliest predictable date that a generic version could become available. In a court action brought bt Actavis, Millennium's defence of Velcade rests on two US patents (6,713,446 and 6,958,319) which were filed in 2005 and are both due to expire on January 5, 2022.