The FDA approved and granted a priority review to the new drug application (NDA) for capmatinib (INC280), according to Novartis, the drug’s developer.
The MET inhibitor, capmatinib, is being analyzed as a potential first-line treatment for previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14)-mutated non-small cell lung cancer (NSCLC).
As it stands, there are currently no approved therapies that target METex14-mutated advanced NSCLC, meaning if approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer.
“We are extremely encouraged by the FDA’s priority review designation for capmatinib, a MET inhibitor that may be a major treatment advance for patients with this particularly aggressive form of lung cancer,” John Tsai, MD, head of global drug development and chief medical officer at Novartis, said in a news release.
METex14 mutations occur in 3%-4% of newly diagnosed advanced NSCLC cases.
The NDA was supported by encouraging results from the GEOMETRY mono-1 phase II study in which the overall response rate was 67.9% (95% CI, 47.6-84.1) and 40.6% (95% CI, 28.9-53.1) among treatment-naïve and previously treated patients, respectively.
Even more, median duration of response was 11.14 months (95% CI, 5.55 to not evaluable) in treatment-naïve patients and 9.72 months (95% CI, 5.55-12.98) in previously treated patients. Common treatment-related adverse events included peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%), and diarrhea (11%).
“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,” continued Tsai.
A priority review shortens the FDA review period from 10 to 6 months if the agency determines the therapy has the potential to “provide significant improvements in the treatment, diagnosis or prevention of serious conditions.” Capmatinib was previously granted breakthrough therapy designation by the FDA.
The drug’s review is expected to be completed within 6 months, according to the release.
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review [news release]. Basel. Published February 11, 2020. https://www.novartis.com/news/media-releases/novartis-announces-met-inhibitor-capmatinib-inc280-first-potential-treatment-metex14-mutated-advanced-non-small-cell-lung-cancer-granted-priority-fda-review. Accessed February 11, 2020.