The US Food and Drug Administration (FDA) has granted priority review to the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations after complete disease resection.
Regulatory
FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
FDA grants priority review to Opdivo for resected, high-risk melanoma
The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.
FDA Grants Priority Review to Adjuvant Nivolumab in Melanoma
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.