Posted by Michael Wonder on 30 Oct 2017
European Medicines Agency validates Bristol-Myers Squibb’s Type II variation application for Opdivo (nivolumab) for treatment of patients with resected high-risk advanced melanoma
30 October 2017 - Application is based on results from the Phase 3 CheckMate-238 study.
Bristol-Myers Squibb Company today announced that the 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.
“Patients with advanced melanoma often face a poor prognosis and have a disease recurrence rate of 68% or greater, highlighting the need for more effective adjuvant treatments,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “The validation of our application by the EMA is another step forward in our effort to advance Immuno-Oncology treatments for patients with resected high-risk advanced melanoma.”
