China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) for sunvozertinib has been accepted for review by the US FDA with priority review status. The EGFR inhibitor is targeting approval to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Previous Approvals and Recognitions
Sunvozertinib was first approved in China in August 2023, becoming the sole standard treatment for EGFR exon20ins NSCLC in the second-line/posterior line setting. In the US, the molecule has previously been awarded multiple Breakthrough Therapy Designations (BTDs) by the FDA for the EGFR exon20ins NSCLC indication, covering all lines of treatment.
Clinical Trial Results
The NDA filing is supported by results from the WU-KONG1B, a multinational pivotal study evaluating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC patients. Sunvozertinib met the primary endpoint, demonstrating its best-in-class potential with “high efficiency and low toxicity” on a global scale.
Significance of the Priority Review
The priority review status underscores the potential of sunvozertinib to offer a significant therapeutic benefit for patients with EGFR exon20ins NSCLC. This development highlights Dizal Pharmaceutical’s commitment to advancing innovative treatments for lung cancer and improving patient outcomes globally.-Fineline Info & Tech
