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European Medicines Agency recommends Janssen Velcade to treat mantle cell lymphoma

The European Medicines Agency’s (EMA) Medicinal Products for Human Use (CHMP) has given a positive opinion for Janssen-Cilag International’s Velcade for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

MCL

Velcade covers use of bortezomib along with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated MCL, who are unsuitable for haematopoietic stem cell transplantation.

The positive opinion was based on data from LYM-3002, a randomised, open-label, active-controlled, multicentre, international, prospective Phase 3 study featuring 487 patients with newly diagnosed MCL who were ineligible, or not considered, for bone marrow transplantation.

Janssen Europe, Middle East and Africa (EMEA) Medical Affairs vice-president Thomas Stark said: "This positive opinion brings us one step closer to offering additional treatment options with Velcade for patients and physicians, and we are delighted with this recommendation."

During the study, the newly diagnosed patients with MCL were treated with a Velcade-based combination (VR-CAP), and highlighted significant benefits when compared to a widely used standard of care combination not including Velcade (R-CHOP).

Specifically, the VR-CAP regimen was found to significantly improve progression-free survival (PFS), the primary endpoint, while showing improvements across a range of secondary endpoints, as well as additional, but manageable, toxicity when compared to VR-CHOP.

An independent review committee and the study investigators reported the increase in PFS to be 59% and 96%, respectively.

The CHMP’s positive opinion is scheduled to be reviewed by the European Commission before authorising Velcade’s use in MCL, which is anticipated in early 2015.

Co-developed by Millennium and Janssen Pharmaceutical Companies, Velcade is currently indicated for the treatment of multiple myeloma (MM), a rare blood cancer, either as monotherapy or in combination with of other treatment regimens.

MCL is a rare and aggressive type of blood cancer involving the lymph nodes, but can spread to other tissues, such as the bone marrow, liver, spleen and gastrointestinal tract, and is associated with poor prognoses.

The disease impact fewer than 0.45 in 100,000 people in Europe and with a median age at diagnosis of 65.


Image: Micrograph showing mantle cell lymphoma in a biopsy of the terminal ileum. H&E stain. Photo: courtesy of Nephron.