BMS files Yervoy (ipilimumab) for supplemental approval for stage 3 melanoma recurrence.
BMS has announced that the FDA has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy (ipilimumab) 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 October 28, 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 five years, the majority of patients experience disease recurrence, with nearly 90 percent in those considered at the highest risk. Once the disease returns, survival rates have been been very low historically, ranging from 11 to 20 percent.
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.
Comment:The benefits with Yervoy are its ability to increase overall survival in patients with advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. The most common side effects are diarrhoea, rash, puritus, fatigue, nausea, vomiting, decreased appetite and abdominal pain. It is the first new melanoma treatment to extend survival in patients with advanced forms of the cancer.
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