The FDA approved the combination of dabrafenib and trametinib for adjuvant treatment of patients with BRAF V600E- or BRAF V600K-positive melanoma that has spread to their lymph nodes.
Regulatory
Europe Approves New Nivolumab Dosing Schedules
A 4-week dosing schedule for nivolumab (Opdivo) has been approved by the European Commission for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC), Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor, has announced.
Melanoma: FDA Approves Adjuvant Dabrafenib With Trametinib
The US Food and Drug Administration (FDA) approved dabrafenib with trametinib as an adjuvant therapy following complete resection for patients with BRAFV600E- or V600K-mutated melanoma with lymph node involvement, according to a press release.1
European Panel Backs New Nivolumab Dosing Schedules
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended adding the option of a 4-week dosing schedule to the label for nivolumab (Opdivo) for the treatment of patients with advanced melanoma and previously treated renal cell carcinoma (RCC).1