Novartis wins FDA’s breakthrough tag for lung cancer hopeful

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FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann

ZURICH (Reuters) – Novartis has secured the U.S. Food and Drug Administration’s Breakthrough Therapy Designation for its investigational medicine capmatinib, which it aims to file for approval later this year against a mutated form of lung cancer.

Novartis is aiming to win approval for oral capmatinib as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), a form of the disease for which there are no targeted therapies now, the Basel-based company said on Friday.

(This story fixes typographical error in first paragraph)

Reporting by John Miller; Editing by Michael Shields and David Goodman

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