Dr Bazhenova on the FDA Approval of Sunvozertinib for EGFR-Mutated mNSCLC

“Sunvozertinib [is] another treatment option for patients with EGFR exon 20 insertion [mutations].”

Lyudmila A. Bazhenova, MD, a clinical professor of medicine at the University of California San Diego (UCSD); as well as a medical oncologist at the UCSD Moores Cancer Center, discussed the significance of the FDA approval of sunvozertinib (Zegfrovy) for patients with EGFR-mutated metastatic non–small cell lung cancer (NSCLC).

On July 2, 2025, the FDA granted accelerated approval to sunvozertinib for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This regulatory decision was backed by data from the phase 1/2 WU-KONG1B trial (NCT03974022), in which, among 85 efficacy-evaluable patients who received sunvozertinib at the recommended dose of 200 mg once daily with food, the overall response rate was 46% (95% CI, 35%-57%). The duration of response was 11.1 months (95% CI, 8.2-not evaluable).

The sunvozertinib prescribing information includes precautions and warnings for interstitial lung disease/pneumonitis, dermatological adverse effects (AEs), gastrointestinal AEs, ocular toxicity, and embryo-fetal toxicity.

This approval expands the treatment options that are available for patients with NSCLC harboring EGFR exon 20 insertion mutations, Bazhenova began. The first-line standard of care for this patient population in the US is carboplatin plus pemetrexed and amivantamab-vmjw (Rybrevant), supported by data from the phase 3 PAPILLON trial (NCT04538664), she explained. The availability of sunvozertinib positions this agent as the ideal second-line treatment option for patients who have previously received the PAPILLON regimen, according to Bazhenova.

Historically, the NSCLC treatment paradigm lacked approved TKIs for patients with EGFR exon 20 insertion mutations, Bazhenova said. The indication for the EGFR TKI mobocertinib (Exkivity) for the treatment of adult patients with EGFR exon 20 insertion mutation–positive, locally advanced or metastatic NSCLC following disease progression on platinum-based chemotherapy was voluntarily withdrawn in the US in 2023. Therefore, the FDA approval of sunvozertinib adds a convenient oral TKI treatment option to this armamentarium, she concluded.