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Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping

Web Exclusives - FDA Updates

On May 6, 2020, the FDA accelerated the approval of oral capmatinib (Tabrecta; Novartis), a kinase inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC). Capmatinib is the first agent approved by the FDA for the treatment of metastatic NSCLC associated with mutations that lead to mesenchymal-epithelial transition (MET) exon 14 skipping, as determined by an FDA-approved test. The FDA granted capmatinib breakthrough therapy and orphan drug designations.

On the same day, the FDA also approved Foundation Medicine’s FoundationOne CDx assay (F1CDx) as a companion diagnostic to capmatinib. F1CDx is a next-generation sequencing–based in vitro diagnostic device that can detect several mutations, including mutations that lead to MET exon 14 skipping.

“Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations, with drugs being developed to target these specific groups,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “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,” he said.

“In the face of the COVID-19 pandemic, our regular work on reviewing treatments for patients with cancer is moving forward. The impact may be hardest on those with acute or chronic medical conditions and those with weakened immune systems, such as that caused by cancer and some forms of cancer treatment,” Dr Pazdur added.

NSCLC is the most common type of lung cancer and is associated with a high risk for metastasis. MET exon 14 skipping is often involved in cancer metastasis, and 3% to 4% of patients with NSCLC have mutations leading to MET exon 14 skipping.

The FDA approval of capmatinib was based on the results of a clinical trial of patients with NSCLC and mutations leading to MET exon 14 skipping; all patients had negative status for EGFR and ALK gene mutations. The patients received oral capmatinib 400 mg twice daily until disease progression or unacceptable toxicity. The primary efficacy end point was overall response rate (ORR); the secondary end point was duration of response.

In all, 28 patients had never received treatment for NSCLC, whereas 69 patients had received previous therapy. The ORR for the 28 treatment-naïve patients was 68%, which included 4% complete responses and 64% partial responses. The ORR for the 69 patients who had received previous therapy was 41%, all being partial responses. Of the patients who had a response to capmatinib therapy, 47% of treatment-naïve patients and 32.1% of those who had previously received therapy for NSCLC had a response lasting ≥12 months.

The common side effects seen with capmatinib were peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. The serious side effects with capmatinib treatment included interstitial lung disease or pneumonitis; patients with these serious side effects should discontinue capmatinib therapy permanently. Capmatinib may also cause hepatotoxicity, which would require dose reduction or permanent treatment discontinuation.

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Last modified: May 12, 2020