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FDA approval for Novartis' melanoma combo


The FDA has approved Novartis’ Tafinlar(dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma, as detected by an FDA-approved test, and involvement of lymph nodes, following complete resection.
The FDA granted the drug combination Breakthrough Therapy Designation in October 2017 and Priority Review in December 2017. It is currently under review in Europe.
In a statement Novartis said that the Tafinlar/Mekinist combo is the first oral targeted adjuvant combination therapy to demonstrate significant clinical benefit in patients with a BRAF V600 mutation, following complete surgical resection. In trials it was shown to significantly reduce the risk of disease recurrence or death compared to placebo by 53 percent
“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, CEO, Novartis Oncology. “Today’s FDA approval is an important milestone for patients who previously had limited treatment options in the adjuvant setting, and reflects our commitment to the ongoing development of this breakthrough treatment.”