The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ZEGFROVY (sunvozertinib), a novel oral therapy developed by Dizal, for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (exon20ins) whose disease has progressed following platinum-based chemotherapy. This approval makes ZEGFROVY the first and only targeted oral treatment available in the U.S. for this rare and difficult-to-treat subset of NSCLC.
ZEGFROVY, which received both Breakthrough Therapy Designation and Priority Review from the FDA, was approved under the agency’s Accelerated Approval pathway, based on overall response rate and duration of response. Continued approval may be subject to confirmation of clinical benefit in a larger study.
“ZEGFROVY represents a first-in-class oral therapy offering improved safety, efficacy, and convenience for NSCLC patients with EGFR exon20ins,” said Dr. Xiaolin Zhang, CEO of Dizal. “This milestone underscores our mission to bring transformative therapies to patients with significant unmet needs.”
The FDA’s decision is supported by data from the global WU-KONG1B clinical trial, which demonstrated significant and consistent antitumor activity across diverse populations. These results were featured in an oral presentation at the 2024 ASCO Annual Meeting and accepted for publication in the Journal of Clinical Oncology.
“ZEGFROVY significantly improves treatment options for this underserved group,” said Dr. Pasi A. Jänne of Dana-Farber Cancer Institute, the trial’s lead investigator. “Its once-daily oral dosing enhances patient adherence and reflects a shift toward chronic disease management in lung cancer.”
Experts highlighted the unique challenges of treating EGFR exon20ins mutations, which are the third most common type of EGFR mutation and are associated with poor prognosis and limited treatment options. ZEGFROVY’s design allows for potent, selective inhibition of a broad range of EGFR mutations while sparing healthy tissue.
In conjunction with the approval, the FDA also approved Thermo Fisher Scientific’s Oncomine Dx Express Test as a companion diagnostic to identify eligible patients. Using next-generation sequencing, the test can detect EGFR exon20ins mutations in as little as 24 hours.
Dizal has completed enrollment for its phase 3 WU-KONG28 trial, comparing ZEGFROVY to standard chemotherapy in newly diagnosed patients. Preliminary data from earlier trials showed a confirmed objective response rate of 78.6% and a median progression-free survival of 12.4 months, supporting its potential as a first-line treatment.
ZEGFROVY was previously approved in China in August 2023 and now becomes available to patients in the U.S., expanding global access to a critical new therapy for a challenging form of lung cancer.