FDA Accepts Supplemental BLA for Yervoy as Adjuvant Melanoma Treatment

Monday, March 9, 2015

Source: Healio

Bristol-Myers-Squibb recently announced that the FDA has accepted a supplemental biologics license application for filing and review of Yervoy as adjuvant treatment in patients with stage 3 melanoma who are at high risk for recurrence after complete surgical resection.

Yervoy (ipilimumab), is a recombinant, human monoclonal antibody that blocks cytoxic T-lymphocyte-associated antigen-4, according to a press release. It was approved in 2011 by the FDA as 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma.

Filing acceptance was based on clinical data from the randomized, double-blind, phase 3 trial, CA184-029 (EORTC 18071), which assessed the efficacy of ipilimumab at an investigational dose of 10 mg/kg in preventing or delaying recurrence after complete resection of high-risk stage 3 melanoma.

FDA action on the supplemental BLA is expected by Oct. 28, 2015, the release stated.

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