Dabrafenib/Trametinib Combination Approved in BRAF-Mutant Melanoma

Source: Cancer Network, June 2018

The US Food and Drug Administration (FDA) granted approval to the combination of dabrafenib (Tafinlar, Novartis) and trametinib (Mekinist, Novartis) for the adjuvant treatment of melanoma. Specifically, the combination is approved for patients with a BRAF V600E or V600K mutation and involvement in the lymph nodes, after complete resection of the tumor.
“Since the initial approval of Tafinlar and Mekinist in metastatic melanoma in 2013, the combination has become an important therapy for many patients carrying a BRAF mutation in both melanoma and lung cancers,” said Liz Barrett, the CEO of Novartis Oncology, in a press release. “Today’s FDA approval is an important milestone for patients who previously had limited treatment options in the adjuvant setting.”
The FDA previously granted both Breakthrough Therapy Designation and Priority Review to the combination of dabrafenib and trametinib. The approval is based on results of the COMBI-AD trial, a phase III study that included 870 patients with stage III melanoma and a BRAF mutation, as well as lymph node involvement.