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.
Regulatory
FDA Approves Frontline Opdivo for Advanced Melanoma
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.
Dr. Georgina Long on Dabrafenib and Trametinib in BRAF-Mutated Melanoma
Georgina Long, BSc, PhD, MBBS, FRACP, medical oncologist, translational researcher, Melanoma Institute Australia, The University of Sydney, discusses which patients may benefit from the combination of dabrafenib and trametinib based on several recent clinical trials.
The FDA just granted a full approval of dabrafenib and trametinib for patients with unresectable or metastatic BRAF-mutated melanoma.
FDA approves Cotellic-Zelboraf combination to treat advanced melanoma
The US Food and Drug Administration (FDA) has granted approval for Roche’s Cotellic (cobimetinib) in combination with Zelboraf (vemurafenib) to treat people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.