publication date: Feb. 13, 2015

E.U. Expands Velcade Label; ODAC to Examine Talimogene Laherparepvec in Melanoma

 

The European Commission approved a variation to the terms of the marketing authorization of Velcade (bortezomib), in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for blood stem-cell transplantation.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency on Dec. 18, 2014. This approval allows for the marketing of Velcade for the above indication in all 28 countries of the European Union. The approval of Velcade in MCL is based on data from the phase III LYM-3002 study.

In the E.U., Velcade is currently indicated for the treatment of multiple myeloma either as monotherapy or in combination with other treatment regimens.

LYM-3002 was a randomized, open-label, prospective phase III study including 487 patients with newly diagnosed MCL who were ineligible or not considered for bone marrow transplantation.

The study compared patients with MCL using the Velcade-based combination, compared to a standard of care combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. The Velcade combination significantly improved progression-free survival, the primary endpoint.

An independent review committee reported the increase in PFS to be 59 percent (median 24.7 vs. 14.4 months; HR 0.63; p<0.001), whereas the study investigators reported the increase in PFS to be 96 percent (median 30.7 vs. 16.1 months; HR 0.51; p<0.001).

In 2006, the FDA approved Velcade for the treatment of patients with MCL who have received at least one prior therapy, with a subsequent frontline treatment approval in October 2014 for Velcade in combination with … Continue reading 41-06 E.U. Expands Velcade Label; ODAC to Examine Talimogene Laherparepvec in Melanoma

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