Novartis drug combination for aggressive skin cancer fully approved for human use

Novartis announced on Friday that the US Food and Drug Administration (FDA) has provided a regular approval for its new drug combination for treatment of metastatic melanoma.

The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) is intended for patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma, diagnosed with the help of a FDA-approved test. The drug combination is the first targeted therapy combination to show more than two years of survival in patients with metastatic melanoma.

Melanoma is one of the most serious form of skin cancer. It occurs when “unrepaired DNA damage to skin cells trigger genetic changes that cause them to form malignant tumours,” according to Novartis. Metastatic melanoma is one of the most aggressive forms of skin cancer in which melanoma spreads to other parts of the body. The condition is difficult to treat and can even prove fatal.

"This approval of the combination in the US allows us to communicate more broadly with the melanoma community about the role of targeted therapies, our data, the possibility to improve clinical outcomes for patients, and our commitment to develop these medicines to their fullest potential," said Bruno Strigini, President of Novartis Oncology, in a press statement.

The initial approval for the drug combination was provided in 2014 under the FDA's Accelerated Approval program. The approval was based on the Phase II data, which was reviewed under a priority review designation. During the clinical trials, more than 5,000 patients with BRAF mutation-positive metastatic melanoma received Tafinlar + Mekinist combination treatment.

It is estimated that 200,000 new cases of metastatic melanoma are diagnosed each year around the world. Out of all the patients who are diagnosed with late-stage metastatic melanoma, only 20 percent survive for at least five years.

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