Millennium Pharmaceuticals (NASDAQ:MLNM) announced that its multiple myeloma (MM) drug Velcade has been granted priority review by the U.S. Food and Drug Administration. Millenium is looking for a new indication to allow newly diagnosed MM patients to be treated with Velcade.
Data submitted to the FDA for the supplemental New Drug Application (sNDA) included data from the phase III VISTA study which was a large, international clinical trial that compared Velcade to traditional treatment. Velcade is already the market leader for MM patients that have attempted at least one prior therapy.
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Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., chief medical officer, Millennium. "The rapid action by the FDA puts us one step closer to establishing Velcade based therapies as a standard of care for patients with newly diagnosed multiple myeloma."
The VISTA trial consisted of 682 patients who had been newly diagnosed MM and who ever ineligible for stem cell transplantation. Velcade, melphalan and prednisone was compared to the traditional regime of melphalan and prednisone. The study demonstrated significant improvement across all endpoints including complete remission, disease progression and survival.
[Source: PharmaBiz]
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