FDA Accepts sBLA for Yervoy as Adjuvant Treatment for Patients with Stage 3 Melanoma

Bristol-Myers Squibb Company (BMS) has announced that FDA has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection. The projected FDA action date is 28 October 2015.

For many stage 3 melanoma patients, there is a high risk of disease recurrence and there has been a low overall survival rate. By 5 years, the majority of patients experience disease recurrence, with nearly 90% in those considered at the highest risk. Once the disease returns, survival rates have been been very low historically, ranging from 11 to 20%.

“Four years ago, Yervoy was approved for the treatment of unresectable or metastatic melanoma, the most advanced form of the disease,” said Michael Giordano, senior vice president, Head of Development, Oncology, BMS. “Today’s announcement is a reflection of our commitment to investigate our immuno-oncology treatments for patients across lines of therapy and stages of the disease.”

This filing acceptance is based on clinical data from a randomized, double-blind Phase III trial, CA184-029 (EORTC 18071), assessing the efficacy of Yervoy, at the investigational dose of 10 mg/kg, in preventing or delaying recurrence after complete resection of high-risk stage 3 melanoma.