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FDA Approves Mobocertinib for NSCLC With EGFR Exon 20 Insertion Mutations

By: JNCCN 360 Staff
Posted: Friday, September 17, 2021

On September 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the oral therapy mobocertinib (Exkivity; TAK-788) for locally advanced or metastatic non–small cell lung cancer with EGFR exon 20 insertion mutations in adults whose disease progressed on or after platinum-based chemotherapy. The FDA also approved the Oncomine Dx Target Test, a companion diagnostic device that can identify eligible candidates for mobocertinib treatment. Continued approval for mobocertinib is contingent on a future confirmatory trial. Mobocertinib is a first-in-class, oral tyrosine kinase inhibitor that specifically targets EGFR exon 20 insertion mutations.

The FDA approval is based on the international, open-label, multicohort Study 101 clinical trial. The trial enrolled 114 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. The median age of patients was 60 years, with 66% being female and 60% being of Asian descent.

Patients were given a daily oral dose of 160 mg of mobocertinib until disease progression or unacceptable toxicity. Results showed a 28% overall response rate, and the median response duration was 17.5 months. The confirmed disease control rate was 78%. Results showed a median overall survival of 24 months in patients treated with mobocertinib. Additionally, the median progression-free survival was 7.3 months.

The most common adverse reactions observed in more than 20% of patients taking mobocertinib included diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain.

The recommended dose is 160 mg orally once daily until disease progression or unacceptable toxicity. For full prescribing information, visit accessdata.fda.gov.



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