Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.
These mutations are identified by an FDA-approved test in patients.
Sunvozertinib, an irreversible EGFR inhibitor, is designed to target a broad range of mutations while maintaining selectivity for wild-type EGFR.
The NDA submission is supported by data from the WU-KONG1 Part B multinational trial that evaluated the safety and efficacy of sunvozertinib in patients with relapsed or refractory EGFR exon20ins NSCLC across Asia, North America, South America, and Europe.
Findings showed that sunvozertinib achieved the primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate.
Dizal CEO Xiaolin Zhang said: “We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC.
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“The filing for approval of sunvozertinib marks Dizal’s first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application.”
The therapy received accelerated approval in China, reportedly becoming the first and only oral medication globally for NSCLC patients harbouring EGFR exon20ins mutations.
It has also earned breakthrough therapy designations (BTDs) from the FDA this April and China’s Center for Drug Evaluation in October this year for the given indication.
Presently, sunvozertinib is undergoing further evaluation in a Phase III, randomised, multinational WU-KONG28 trial for comparing it with platinum doublet chemotherapies in treatment-naive patients on a global scale.
In August last year, China’s National Medical Products Administration approved sunvozertinib for treating advanced NSCLC with EGFR exon20ins following platinum-based chemotherapy.
