FDA To Review Takeda’s sNDA For Velcade

Published: 03-Sep-2009

Containing long-term survival data for Velcade for injection

FDA has accepted to review Takeda’s supplemental new drug application (sNDA) based on long-term overall survival (OS) data from the VISTA 1 trial. The study examined the use of Velcade-based therapy in patients with previously untreated multiple myeloma (MM).

Vista trail, conducted by Millennium Pharmaceuticals (Millennium) was a multicenter, international phase III clinical trial. It compared Velcade in combination with melphalan and prednisone (VcMP) versus melphalan and prednisone (MP) alone, in patients with previously untreated MM who were not eligible for stem cell transplantation.

Reportedly, in VISTA, the VcMP arm demonstrated a significant improvement in all efficacy endpoints, including time-to-tumor progression, complete response, overall response, progression-free survival and OS compared to the MP arm.

Nancy Simonian, CMO, Millennium, said: “This is the largest phase III registration study to report long-term overall survival in previously untreated multiple myeloma patients.This submission of data from the pre-planned long-term survival assessment represents an important milestone in the development of Velcade.”

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