BRIEF—EMA validates B-MS' type II variation for Opdivo in resected high-risk advanced melanoma

The European Medicines Agency (EMA) has validated Bristol-Myers Squibb’s type II variation application 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 US pharma major’s 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 III, randomized double-blind study of Opdivo versus Yervoy (ipilimumab), an earlier B-MS immuno-oncology drug.