On July 2, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sunvozertinib (Zegfrovy), a selective EGFR tyrosine kinase inhibitor, for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
The FDA also approved the Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting EGFR exon 20 insertion mutations in patients with NSCLC who may be eligible for treatment with sunvozertinib.
WU-KONG1B
Efficacy was evaluated in WU-KONG1B (ClinicalTrials.gov identifier NCT03974022), a multinational, open-label, dose randomization trial. Eligible patients had locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations with disease progression on or after platinum-based chemotherapy. The primary efficacy population included 85 patients who received 200 mg of sunvozertinib orally once daily with food until disease progression or intolerable toxicity.
The major efficacy outcome measure was confirmed overall response rate according to Response Evaluation Criteria in Solid Tumors version 1.1 as evaluated by a blinded independent review committee. An additional efficacy outcome measure was duration of response by blinded independent review committee. The overall response rate was 46% (95% confidence interval [CI] = 35%–57%), and the duration of response was 11.1 months (95% CI = 8.2 months to not evaluable).
The sunvozertinib prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryofetal toxicity.
The recommended sunvozertinib dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted Priority Review. Sunvozertinib also received Breakthrough Therapy designation.
