Novartis Melanoma Treatment Awarded FDA Breakthrough Designation
23 October 2017 - 5:20PM
Dow Jones News
By Max Bernhard
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.
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
October 23, 2017 02:05 ET (06:05 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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