Categorized | Melanoma News, Regulatory

FDA approves Tafinlar-Mekinist combination for adjuvant treatment of BRAF-mutant melanoma

Source: Healio, May 2018

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.
The combination of the BRAF inhibitor dabrafenib (Tafinlar, Novartis) and the MEK1/2 inhibitor trametinib (Mekinist) previously had been approved for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as well as for treatment of BRAF V600E mutation-positive non-small cell lung cancer.
The FDA based the new indication on results from the phase 3 COMBI-AD study, which included 870 patients with stage III BRAF V600E- or V600K-mutation positive melanoma who had undergone complete surgical resection.
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