FDA Grants Priority Review to Novartis Lung Cancer Treatment

February 13, 2020

If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer.

Novartis announced on Feb. 11, 2020 that FDA accepted and granted priority review to a new drug application (NDA) for capmatinib, a mesenchymal–epithelial transition (MET) inhibitor for the treatment of first line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14)-mutated non-small cell lung cancer.

According to a company press release, FDA’s decision comes after positive results from a Phase II study that showed a 67.9% overall response rate and a 40.6% response rate from treatment-naïve and previously treated patients. If approved, this treatment will be the first therapy targeted for METex14-mutated advanced lung cancer, according to Novartis.

“We are extremely encouraged by [FDA’s] [p]riority [r]eview designation for capmatinib, a MET inhibitor that may be a major treatment advance for patients with this particularly aggressive form of lung cancer,” said John Tsai, MD, head of Global Drug Development and chief medical officer, Novartis, in the press release. “Results of the geometry mono-1 trial clearly identify METex14 as an oncogenic driver and we are inspired to bring capmatinib, potentially the first METex14 targeted therapy, to patients and to reimagine medicine and outcomes for people with lung cancer.”

Source: Novartis