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The U.S. Food and Drug Administration recently approved Novartis’ Tafinlar (dabrafenib) with Mekinist (trametinib) for adjuvant treatment of melanoma with BRAF V600E and V600K mutations.
The combination treatment is approved in patients with melanoma that has spread to the lymph nodes, and who also have the BRAF V600E/K mutation-positive gene.
“Today’s FDA approval is an important milestone for patients who previously had limited treatment options in the adjuvant setting,” said Novartis Oncology CEO Liz Barrett, “and reflects our commitment to the ongoing development of this breakthrough treatment.”
The approval for this indication came after findings from the COMBI-AD phase three study of 870 patients with stage 3 BRAF V600E/K mutation-positive melanoma who were treated with the drug combination after complete surgical resection. Patients were given Tafinlar (150 mg BID) + Mekinist (2 mg QD) combination (n=438) or matching placebos (n=432). Those who received the combination therapy demonstrated a significantly reduced risk of disease recurrence or death by 53 percent, compared to placebo (HR: 0.47 [95 percent CI: 0.39-0.58]; p<0.0001).
Researchers noted relapse-free survival benefit across all patient subgroups for those in the combination arm, including disease substage. Results of the study were published in the October 2017 issue of the New England Journal of Medicine.
Tafinlar and Mekinist were first approved for treatment of metastatic melanoma in 2013.
“We developed the first adjuvant therapy approved by the FDA 22 years ago, and now we have the first effective oral targeted therapy combination that prevents relapse among patients with BRAF-mutated melanoma that has spread to lymph nodes,” John M. Kirkwood, M.D., director of Melanoma and Skin Cancer, University of Pittsburgh, stated in the news release.