FDA Updates OS Label Data for Bortezomib in Myeloma

December 2011, Vol 2, No 7

The FDA approved an update to the label of bortezomib (Velcade, Takeda) to include the newly reported 5-year OS data showing survival advantage when the drug is added to melphalan and prednisone (VMP) for patients with previously untreated multiple myeloma.

These longest available follow-up data for patients with myeloma show that patients who received the VMP regimen continued to have signif - icantly longer OS (median 56.4 months) than those who received the melphalan and prednisone regimen without bortezomib (median, 43.1 months).

The newly released data from the trial were presented at the 2011 American Society of Hematology meeting (see article on page 1). (November 1, 2011)

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