Velcade in Combination Chemo Good Against Mantle Cell Lymphoma

Janssen has applied to the European Medicines Agency (EMA) to expand the label for Velcade (bortezomib) to include treatment of adult patients with previously untreated mantle cell lymphoma.

Specifically, they are seeking approval to add Velcade to frontline therapy for MCL when used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR-CAP).

MCL is a rare, often aggressive, B-cell non-Hodgkin's lymphoma that usually occurs in older adults.

Currently the EMA has licensed Velcade 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."

Data is derived from the LYM-3002 trial, results of which were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 19th Annual Congress of the European Hematology Association (EHA). Trial participants were randomized to receive VR-CAP or R-CHOP. VR-CAP was shown to significantly improve progression-free survival (PFS) and showed improvements across other secondary endpoints.

However, VR-CAP was associated with additional toxicity and more serious adverse events than R-CHOP.

Source: MarketwWatch