Novartis investigational lung cancer therapy grabs breakthrough status

Sept. 9, 2019

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