FDA Grants Accelerated Approval to Sunvozertinib for Metastatic EGFR-Positive NSCLC

The FDA has granted accelerated approval to sunvozertinib (Zegfrovy, Dizal Pharmaceutical Co, Ltd) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have EGFR exon 20 insertion mutations, as detected by an FDA-approved test.  The accelerated approval is for patients whose disease has progressed on or after platinum-based chemotherapy.

The organization previously granted priority review and breakthrough therapy designation to the application for the drug.

Simultaneously, 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 Zegfrovy.”

The FDA announcement highlighted that WU-KONG1B, a multinational, open-label, dose randomization trial evaluated the efficacy of the drug in 85 patients who were diagnosed with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who experienced disease progression on or after platinum-based chemotherapy.

Eligible participants received 200 mg orally of sunvozertinib once daily with food “until disease progression or intolerable toxicity.”

Overall response rate (ORR) was listed as the main efficacy outcome and duration of response (DOR) was listed as an additional efficacy outcome. ORR was confirmed via RECIST v1.1 through an assessment by a blinded independent review committee. The study ORR was 46% (95% CI: 35, 57) and the DOR was 11.1 months (95% CI: 8.2, not evaluable).

Furthermore, FDA officials emphasized that prescribers should be aware of the medication’s warnings and precautions, which include interstitial lung disease or pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.

“The recommended sunvozertinib dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity,” officials explained in the announcement.