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The FDA granted for the mesenchymal-epithelial transition (MET) inhibitor capmatinib (Tabrecta) for metastatic MET-mutated non-small cell lung cancer (NSCLC).

The approval applies specifically to NSCLC with the MET exon 14 skipping (METex14) mutation, which accounts for 4,000 to 5,000 cases of NSCLC each year in the United States, . The FDA simultaneously approved the FoundationOne CDx assay as a companion diagnostic test for the MET mutation.

"Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations with drugs being developed to target these specific groups," Richard Pazdur, MD, of the FDA Office of Oncologic Diseases, said in a statement. "Tabrecta is the first approval specifically for the treatment of patients with non-small cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy, which they didn't have prior to today."

Support for the approval came from a phase II clinical trial with metastatic METex14 NSCLC and no EGFR or ALK mutations. The trial's primary outcome was objective response rate, and 69 patients were evaluable for the endpoint.

Data analysis included 28 patients with no prior treatment for NSCLC and 69 patients who had received one or more prior therapies. Treatment with capmatinib led to objective responses in 19 of 28 (68%) untreated patients and 28 of 69 (41%) treated patients. One previously untreated patient had a complete response.

Duration of response was a key secondary outcome. In the cohort of untreated patients, 47% of responses lasted 12 months or longer, as did 32% of responses in patients with previously treated disease.

The most common side effects associated with capmatinib were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

As a condition of the accelerated approval, the company must conduct additional studies to confirm the phase II trial results.

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