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.
Regulatory
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.
FDA approves Cotellic as part of combination treatment for advanced melanoma
The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).