FDA News

FDA grants capmatinib priority review for non-small cell lung cancer subset

The FDA granted priority review to capmatinib for the treatment of patients with advanced non-small cell lung cancer who harbor MET exon 14 skipping mutations.

Capmatinib (INC280; Novartis, Incyte) is an investigational oral agent that inhibits MET. The drug will be evaluated as first-line treatment and for previously treated patients with locally advanced or metastatic MET exon 14 skipping-mutated NSCLC.

NSCLC comprises approximately 85% of new lung cancer cases, and about 3% to 4% of newly diagnosed advanced NSCLC cases feature MET exon 14 skipping mutations.

The FDA previously granted breakthrough therapy designation to capmatinib for this lung cancer subset, as reported by Healio. Priority review for capmatinib will shorten the FDA review period on the manufacturer’s new drug application from the standard 10 months to 6 months.

Novartis supported the new drug application for capmatinib with results of the phase 2 GEOMETRY mono-1 trial, which showed an overall response rate of 67.9% (95% CI, 47.6-84.1) among previously untreated patients and 40.6% (95% CI, 28.9-53.1) among previously treated patients. Median duration of response was 11.14 months (95% CI, 5.55-not estimable) among previously untreated patients and 9.72 months (95% CI, 5.55-12.98) among previously treated patients.

The most common treatment-related adverse events associated with capmatinib included peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%).

“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 company-issued press release. “Results of the GEOMETRY mono-1 trial clearly identify [MET exon 14 skipping mutations] as an oncogenic driver, and we are inspired to bring capmatinib, potentially the first [MET exon 14 skipping mutation-targeted] therapy, to patients and to reimagine medicine and outcomes for people with lung cancer.”

The FDA granted priority review to capmatinib for the treatment of patients with advanced non-small cell lung cancer who harbor MET exon 14 skipping mutations.

Capmatinib (INC280; Novartis, Incyte) is an investigational oral agent that inhibits MET. The drug will be evaluated as first-line treatment and for previously treated patients with locally advanced or metastatic MET exon 14 skipping-mutated NSCLC.

NSCLC comprises approximately 85% of new lung cancer cases, and about 3% to 4% of newly diagnosed advanced NSCLC cases feature MET exon 14 skipping mutations.

The FDA previously granted breakthrough therapy designation to capmatinib for this lung cancer subset, as reported by Healio. Priority review for capmatinib will shorten the FDA review period on the manufacturer’s new drug application from the standard 10 months to 6 months.

Novartis supported the new drug application for capmatinib with results of the phase 2 GEOMETRY mono-1 trial, which showed an overall response rate of 67.9% (95% CI, 47.6-84.1) among previously untreated patients and 40.6% (95% CI, 28.9-53.1) among previously treated patients. Median duration of response was 11.14 months (95% CI, 5.55-not estimable) among previously untreated patients and 9.72 months (95% CI, 5.55-12.98) among previously treated patients.

The most common treatment-related adverse events associated with capmatinib included peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%).

“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 company-issued press release. “Results of the GEOMETRY mono-1 trial clearly identify [MET exon 14 skipping mutations] as an oncogenic driver, and we are inspired to bring capmatinib, potentially the first [MET exon 14 skipping mutation-targeted] therapy, to patients and to reimagine medicine and outcomes for people with lung cancer.”