FDA approves Exkivity for NSCLC subset
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The FDA approved mobocertinib for treatment of certain patients with non-small cell lung cancer.
The approval applies to use of the agent by adults with locally advanced or metastatic EGFR exon 20 insertion-positive NSCLC whose disease progressed on or after platinum-based chemotherapy.
Mobocertinib (Exkivity, Takeda) is an oral tyrosine kinase inhibitor designed to target EGFR exon 20 insertion mutations.
The FDA based approval on results of a phase 1/phase 2 trial that included 114 patients with EGFR exon 20 insertion-positive NSCLC who received prior platinum-based therapy.
Mobocertinib induced a confirmed overall response rate of 28% per independent review committee assessment. Results showed median duration of response of 17.5 months, median OS of 24 months and median PFS of 7.3 months.
The most common adverse events among mobocertinib-treated patients included diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin and musculoskeletal pain.
“EGFR exon 20 insertion-positive NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs,” Pasi A. Jänne, MD, PhD, director of Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said in a Takeda-issued press release. “The approval of [mobocertinib] marks another important step forward that provides physicians and their patients with a new targeted oral therapy specifically designed for this patient population that has shown clinically meaningful and sustained responses.”
The FDA previously granted priority review, breakthrough therapy and orphan drug designations to mobocertinib for this indication.
The agency also approved the Oncomine Dx Target Test (Thermo Fisher Scientific) as a next-generation sequencing companion diagnostic to identify patients with NSCLC who have EGFR exon 20 insertions.
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