Novartis AG said the U.S. Food and Drug Administration granted breakthrough-therapy designation to its oral drug capmatinib for patients with a rare type of metastatic non-small cell lung cancer.
Non-small cell lung cancer is the most common type of lung cancer, affecting more than 2 million people a year. In about 3% to 4% of these cases, the cancer has the MET exon-14 skipping genetic mutation. As compared to other forms of lung cancers, NSCLC does not respond well to chemotherapy.
The Swiss drug giant is developing capmatinib, or INC280, as a potential first-line, or initial, treatment for NSCLC patients with this specific MET mutation.
The FDA's decision is based on positive primary results from Novartis' study, dubbed Geometry mono-1, which was presented at the American Society of Clinical Oncology conference in June.
The breakthrough-therapy designation will expedite the development and review of capmatinib, for which Novartis intends to formally seek FDA approval in the fourth quarter of 2019. The designation is granted to new therapies that treat serious or life-threatening conditions and are potentially better than existing therapies.
