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The FDA granted accelerated approval to mobocertinib (Exkivity) as a second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, on Wednesday.

Approval of the tyrosine kinase inhibitor (TKI) was based on the results of a presented earlier this year at the American Society of Clinical Oncology annual meeting.

Among the 114 patients in the trial with platinum-chemotherapy-pretreated disease, a confirmed response rate of 28% and a disease control rate of 78% were achieved with mobocertinib, per independent review. Median duration of response was 17.5 months, progression-free survival was 7.3 months, and the median overall survival reached 24 months.

"EGFR Exon20 insertion+ NSCLC is an underserved cancer that we have been unable to target effectively with traditional EGFR TKIs," said Pasi Jänne, MD, PhD, of Dana-Farber Cancer Institute in Boston, in a press release. "The approval of Exkivity (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 drug's continued approval may be contingent on results of a confirmatory trial, Takeda noted.

FDA also approved Thermo Fisher Scientific's Oncomine Dx Target Test as a next-generation sequencing diagnostic test for identifying NSCLC patients with EGFR exon 20 insertions eligible for treatment with mobocertinib.

The only other FDA approved therapy specifically for tumors with exon 20 insertions is amivantamab (Rybrevant), a bispecific antibody.

The most common treatment-related adverse events (TRAEs) with mobocertinib were diarrhea (91%), rash (45%), paronychia (38%), decreased appetite (35%), nausea (34%), dry skin (31%), vomiting (30%), increased blood creatinine (25%), stomatitis (24%), and pruritus (21%). Diarrhea was the only grade ≥3 TRAE, occurring in at least 5% of patients. Adverse events leading to discontinuation included diarrhea and nausea (4% each).

Prescribing information for the drug includes a boxed warning for QTc prolongation and Torsades de Pointes, as well as warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

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