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FDA Accepts Novartis’ sNDA for Stage III Melanoma Treatment

The company was also granted Priority Review designation

By: Betsy Louda

, Contract Pharma

The US Food and Drug Administration has accepted Novartis’ supplemental New Drug Application (sNDA) for filing, and granted Priority Review designation for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, following complete resection. 

 

In October, the FDA also granted Breakthrough Therapy designation to Tafinlar in combination with Mekinist for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.

 

“The FDA’s decision to grant Tafinlar in combination with Mekinist Breakthrough Therapy designation and Priority Review designation validates the potential of the combination to have a significant impact on the lives of melanoma patients treated in the adjuvant setting,” said Samit Hirawat, MD, head of Novartis Oncology Global Drug Development. “There remains a need to address the high risk of recurrence seen in these patients and improve the quality of care they receive.”

 

The designation is based on results from COMBI-AD, a Phase III study evaluating Tafinlar + Mekinist in patients with stage III BRAF V600E/K mutation-positive melanoma after complete resection1. The study met its primary endpoint by significantly reducing the risk of disease recurrence or death by 53%.

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