The U.S. FDA has granted Breakthrough Therapy designation to Novartis' capmatinib, which the drugmaker aims to file for approval later this year to treat a mutated form of lung cancer.
If approved, it would be the first targeted therapy to treat MET exon14 skipping-mutated non-small cell lung cancer (NSCLC). The MET mutation is seen in an estimated 3-4 percent of all patients with NSCLC. These patients are generally older and often have a poor prognosis that can limit lung cancer treatment options.
Treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints. The agency granted Breakthrough Therapy Designation for capmatinib based on positive primary results from the GEOMETRY mono-1 study presented at the 2019 meeting of American Society of Clinical Oncology.
Read the press release