BRIEF — US nod for Novartis combo in new melanoma combo

The US Food and Drug Administration (FDA) has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph nodes, following complete resection.

This combination, from Swiss pharma giant Novartis, was granted Breakthrough Therapy Designation by the FDA for this indication in October 2017 and Priority Review in December 2017.

The new indication represents a new treatment option for patients in the USA with BRAF mutation-positive melanoma at risk of disease recurrence or metastases, and is currently under regulatory review in Europe, Japan, Canada and other countries worldwide.

Liz Barrett, chief executive of Novartis Oncology, said: “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.

“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."