Takeda nabs priority review for Velcade

October 29, 2009

Takeda announced that the FDA has agreed to consider an expedited review of the company’s request to update its label for bortezomib (Velcade) to include long-term survival data in patients with previously untreated multiple myeloma.

Takeda announced that the FDA has agreed to consider an expedited review of the company's request to update its label for bortezomib (Velcade) to include long-term survival data in patients with previously untreated multiple myeloma.

The phase III VISTA study enrolled 682 patients with newly diagnosed multiple myeloma who were randomized to receive bortezomib, in combination with melphalan and prednisone, or melphalan and prednisone alone. Data showed that the time-to-disease progression in patients who received the bortezomib combination treatment was 21 months vs 15 months for the second group. The boretzomib combination demonstrated statistical significance in overall survival with a 39% reduction in risk of death, according to Takeda.

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