FDA Grants Tabrecta a Regular Approval for Certain Patients With Lung Cancer

The Food and Drug Administration (FDA) granted a regular approval to Tabrecta (capmatinib) for adults with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping caused by a mutation, as detected by an FDA-approved test, according to the agency.

Tabrecta was granted an accelerated approval — which was contingent upon further study results — in May 2020, marking it the first targeted drug for this patient population. Now, the FDA decided to give Tabrecta a regular approval based on findings from an additional 63 patients and 22 months of extra follow-up of the GEOMETRY mono-1 clinical trial.

Further results from GEOMETRY mono-1, which led to the drug’s accelerated approval two years ago, showed that 68% of previously untreated patients with NSCLC whose tumors had a mutation leading to MET exon 14 skipping responded to treatment, meaning that their tumors shrunk or disappeared from the drug. Average duration of response was 16.6 months.

In patients who had undergone prior therapy (81% who had one prior therapy; 16% received two; and 3% received three), 44% responded to Tabrecta, and duration of response was 9.7 months.

The most common side effect from Tabrecta, which occurred in 20% or more of patients, were: edema (swelling in the limbs caused by the trapping of fluids), nausea, musculoskeletal pain, fatigue, vomiting, difficulty breathing, cough and decreased appetite.

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