Novartis Melanoma Treatment Awarded FDA Breakthrough Designation

By Max Bernhard Features Dow Jones Newswires

Novartis AG (NOVN.EB) said Monday that it received breakthrough therapy designation from the U.S. Food and Drug Administration for a skin cancer treatment that uses a combination of its Tafinlar and Mekinist drugs.

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The Swiss pharmaceuticals company said its treatment received the FDA's breakthrough designation after a phase III study showed the survival rate for patients treated with the drug combination was 58%, compared with 39% for patients that received a placebo. The combination is used to treat patients with stage-three melanoma following surgical removal.

"We thank the FDA for recognizing the scientific advancement Tafinlar and Mekinist may provide in this adjuvant setting," said Samit Hirawat, head of oncology development for Novartis.

The FDA awards breakthrough designation to drugs that treat serious or life-threatening diseases and show significant improvement over existing treatments.

Write to Max Bernhard at Max.Bernhard@dowjones.com; @mxbernhard

(END) Dow Jones Newswires

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October 23, 2017 02:05 ET (06:05 GMT)