Novartis wins FDA’s breakthrough tag for lung cancer hopeful

Breakthrough Therapy Designation, FDA, FDA/Regulatory, Metastatic MET Exon14 Skipping-Mutated Non-Small Cell Lung Cancer (NSCLC)

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.

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

Reuters source:

https://www.reuters.com/article/us-novartis-breakthrough/novartis-wins-fdas-breakthrough-tag-for-lung-cancer-hopeful-idUSKCN1VR0HG

September 6, 2019/by Reuters Health