FDA Accelerates Approval of Sunvozertinib for EGFR Exon 20+ NSCLC
FDA accelerates approval of sunvozertinib for advanced NSCLC with EGFR mutations, offering new hope for patients after chemotherapy.
US FDA
- The FDA granted accelerated approval to sunvozertinib (Zegfrovy) for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed after platinum-based chemotherapy.
- Efficacy data from the WU-KONG1B trial (NCT03974022) demonstrated a confirmed overall response rate of 46% and a duration of response of 11.1 months for sunvozertinib in this specific patient population.
- The approval includes warnings for potential adverse reactions such as interstitial lung disease, gastrointestinal issues, dermatologic reactions, and ocular toxicity, highlighting the need for careful patient monitoring.
The FDA granted accelerated approval to sunvozertinib for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. This approval specifically targets patients whose disease has progressed on or after platinum-based chemotherapy, offering a new therapeutic option for a challenging subset of NSCLC.
Concurrently with the approval of sunvozertinib, the FDA also approved the Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic device. This test is designed to identify EGFR exon 20 insertion mutations, ensuring that eligible patients can be accurately selected for sunvozertinib treatment.
The accelerated approval for sunvozertinib is based on efficacy data derived from the WU-KONG1B trial, a multinational, open-label, dose randomization study. The primary efficacy population for this approval comprised 85 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who had experienced disease progression following platinum-based chemotherapy. These patients received sunvozertinib at a dose of 200 mg orally once daily with food until disease progression or intolerable toxicity.
The major efficacy outcome measure evaluated in the WU-KONG1B trial was the confirmed overall response rate (ORR), as assessed by a blinded independent review committee (BIRC) according to RECIST v1.1. The study reported an ORR of 46% (95% CI, 35%-57%). An additional key efficacy outcome measure was the duration of response (DOR) by BIRC, which was 11.1 months (95% CI, 8.2 to not evaluable). These findings suggest a clinically meaningful response in a patient population with limited treatment alternatives.
Prescribing information for sunvozertinib includes important warnings and precautions that clinicians should be aware of. These include the potential for interstitial lung disease/pneumonitis, various gastrointestinal adverse reactions, dermatologic adverse reactions, and ocular toxicity. Additionally, embryo-fetal toxicity is a concern, necessitating appropriate counseling for patients of reproductive potential. The recommended dose for sunvozertinib is 200 mg orally once daily, to be taken with food and continued until disease progression or the occurrence of unacceptable toxicity.
