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Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination
October 23, 2017 / 5:46 AM / a month ago

Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

ZURICH (Reuters) - Novartis on Monday said the U.S. Food and Drug Administration has granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery.

FILE PHOTO - A Novartis logo is pictured on its headquarters building in Mumbai April 1, 2013. REUTERS/Vivek Prakash/File Photo

“There is a need for more effective treatment options for stage III melanoma patients at a high risk of recurrence following surgical resection,” Samit Hirawat, head of global drug development at Novartis’ oncology unit, said in a release.

“We thank the FDA for recognizing the scientific advancement Tafinlar and Mekinist may provide in this adjuvant setting.”

Reporting by Brenna Hughes Neghaiwi; Editing by Vyas Mohan

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