Novartis announced on Friday that the U.S. Food and Drug Administration granted regular approval of its combination drug for treating an aggressive skin cancer.
The FDA approved the combination of Tafinlar and Mekinist for treating patients with metastatic melanoma, with the regulatory nod based on two years of overall patient survival.
"We're inspired by the difference Tafinlar + Mekinist can make for patients battling such a serious disease," said Novartis president Bruno Strigini in an official statement, adding that the combination will allow their company to “more broadly” communicate targeted therapies and the data behind them to doctors and patients.
Tafinlar and Mekinist were initially approved last year based on mid-stage data under the accelerated approval platform of the FDA, but would rely on late-stage trial data for complete approval. The combination was purchased by Novartis from GlaxoSmithKline in 2014.
According to the pharmaceutical company, over 5,000 patients were part of clinical trials for the combination, which is indicated in more than 35 countries globally including the United States and European Union.
The Tafinlar and Mekinist combination, however, may cause serious side effects.
“Patients should be advised to contact their doctor immediately for a new wart, skin sore or bump that bleeds or does not heal, or a change in the size or color of a mole,” warned the Novartis statement on top of other safety guidelines.
Metastatic or advanced melanoma remains the most serious, life-threatening skin cancer form – a type linked to low chances of survival that only around 20 percent will make it for at least five years after late-stage disease diagnosis.
Around the world, there are around 200,000 new melanoma cases diagnosed each year, about half of which with BRAF mutations, a gene test-determined key target in treating metastatic condition.
More likely to get melanoma are those with fair skin as well as lighter hair and eye color; many or irregular moles; and a family history of the condition. A melanoma that has spread to other areas is characterized by symptoms such as hardened lumps under skin, swollen or painful lymph nodes, persistent coughs, and swelling of the liver.