EMA Validates Bristol-Myers' Type II Variation Application For Opdivo

(RTTNews) - Bristol-Myers Squibb Company (BMY) said that the European Medicines Agency or EMA validated its type II variation application, which seeks to expand the current indications for Opdivo (nivolumab) to include the treatment of patients with melanoma who are at high risk of disease recurrence following complete surgical resection. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.

The type II variation submitted is based on data from CheckMate -238, an ongoing phase 3, randomized double-blind study of Opdivo 3 mg/kg versus Yervoy (ipilimumab) 10 mg/kg in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma, in which Opdivo met its primary endpoint of recurrence-free survival.