Please follow this link to download the 6th edition of the MMP newsletter.
The FDA has issued a complete response letter to Bristol-Myers Squibb informing the company that additional data were needed for its supplemental biologics license application (sBLA) for the use of single-agent nivolumab (Opdivo) in previously untreated patients with BRAF V600 mutation-positive advanced melanoma. The application was based on the CheckMate-066 trial and additional data for a BRAF-positive group.
The FDA has expanded the approval for single-agent Opdivo (nivolumab) to include the frontline treatment of patients with BRAF wild-type advanced melanoma, based on a substantial improvement in overall survival (OS) compared with the chemotherapy dacarbazine in a phase 3 study.
