FDA Grants Capmatinib Priority Review for Treatment of Patients With METex14 NSCLC

By Cameron Kelsall, /alert Contributor
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The US Food and Drug Administration (FDA) has granted Priority Review to a New Drug Application for the MET inhibitor capmatinib, according to a press release issued by Novartis, the drug’s manufacturer.

The FDA grants Priority Review to therapies that have the potential to significantly improve the treatment, diagnosis and prevention of serious conditions. Priority Review decreases the review period following a New Drug Application’s acceptance to 6 months, rather than 10 months under Standard Review.


Priority review. Source: Getty

Capmatinib could potentially become the first agent approved for the treatment of patients with MET exon 14 skipping (METex14) non–small cell lung cancer (NSCLC), a subtype associated with poor outcomes.

NSCLC accounts for up to 85% of lung cancer diagnoses, with METex14 NSCLC diagnosed in 3% to 4% of patients.

Capmatinib previously received Breakthrough Therapy designation from the FDA. The current New Drug Application came as a result of findings in the phase 2 GEOMETRY mono-1 study, which showed that treatment with capmatinib elicited an overall response rate of 67.9% (95% CI, 47.6-84.1) among treatment-naive patients with METex14 NSCLC and 40.6% (95% CI, 28.9-53.1) among previously treated patients, with durable responses sustained in both cohorts.

Treatment with capmatinib was well tolerated. The most common treatment-emergent adverse events were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%).

In addition, Novartis has partnered with Foundation Medicine, Inc., to develop tumor tissue and liquid biopsies to identify METex14 mutations, which are recognized oncogenic drivers.

“We are extremely encouraged by the FDA’s Priority Review designation for capmatinib,” John Tsai, MD, head of global drug development and chief medical officer of Novartis, said 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.”

 

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