Officials with the FDA have granted breakthrough therapy designation to Norvatis’ capmatinib therapy as an initial treatment for metastatic non-small cell lung cancer (NSCLC). Capmatinib is an oral investigational therapy. The research was presented by Dr. Fabrice Barlesi from Aix-Marseille University, France.
“We are pleased to announce that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC),” said John Tsai, MD, Head of Global Drug Development and Chief Medical Officer, Novartis.
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. Treatments that receive Breakthrough Therapy Designation target a serious disease and demonstrate substantial improvement over existing therapies. The FDA granted Breakthrough Therapy Designation for capmatinib based on primary results from GEOMETRY mono-1 study presented at 2019 meeting of American Society of Clinical Oncology.
Novartis is a reimagining medicine that helps to extend the lives of people. Capmatinib is being investigated in a rare form of NSCLC and targets MET-signalling pathway, which is mutated in about 3 to 4% of all NSCLC cases. This mutation leads to tumors which in turn limit treatment options. Novartis revealed phase 2 results from its GEOMETRY mono-1 trial of capmatinib. The BTD process will see development and review of capmatinib expedited.
John Tsai, MD, head of global drug development and chief medical officer of Novartis, said in the release,“We look forward to working with the FDA and global health authorities to bring capmatinib to patients who currently have no available targeted therapy options.”
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