Novartis has obtained approval from the US Food and Drug Administration (FDA) for the use of its Tafinlar (dabrafenib) and Mekinist (trametinib) combination to treat melanoma.
The drug has been approved for patients who have BRAF V600E or V600K mutations, identified using an FDA-approved test, and lymph node involvement after total resection.
Tafinlar blocks the B-Raf enzyme and Mekinist is a MEK inhibitor. The combination therapy secured FDA’s breakthrough therapy and priority review status in October and December 2017, respectively.
This latest approval comes after the review of data from a Phase III clinical trial involving 870 subjects with stage III BRAF V600E/K mutation-positive melanoma following complete surgical resection.
The combination of 150mg Tafinlar with 2mg Mekinist met the primary endpoint of relapse-free survival during the trial. It also minimised the risk of disease recurrence or death by 53%.
Novartis oncology CEO Liz Barrett 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.”
The combination is also approved by the European Medicines Agency for patients with a BRAF V600 mutation in metastatic melanoma and non-small cell lung cancer.