China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA) filing for sunvozertinib (DZD9008), a next-generation epidermal growth factor receptor (EGFR) inhibitor, has been accepted for review by the National Medical Products Administration (NMPA). The drug is indicated for use in locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (Exon20ins) mutations in patients previously treated with platinum chemotherapy.
Clinical Trial Results
The NDA filing is based on the results of the regulatory WU-KONG6 study for sunvozertinib in patients with EGFR Exon20ins mutant advanced NSCLC. The primary endpoint was the clinical overall response rate (cORR) confirmed by a blinded independent committee. As of July 31, 2022, the study demonstrated a cORR of 59.8% at the recommended Phase II dose (RP2D) of 300mg, outperforming similar global products. The overall safety profile was good, with common adverse reactions similar to those of traditional EGFR-TKIs, most of which were grade 1-2.
Market Landscape
Currently, no new drugs targeting EGFR Exon20ins mutant advanced NSCLC have been approved in China. Sunvozertinib’s acceptance for review by the NMPA marks a significant step forward in addressing this unmet need. The drug’s demonstrated efficacy and safety profile position it as a potential new treatment option for patients with this challenging form of lung cancer.
Future Outlook
The acceptance of the NDA filing for sunvozertinib underscores Dizal Pharmaceutical’s commitment to advancing innovative treatments for NSCLC. With its strong clinical data and regulatory progress, sunvozertinib has the potential to make a meaningful impact on patient outcomes. Dizal’s ongoing efforts in oncology highlight its dedication to improving the treatment landscape for patients with advanced lung cancer.-Fineline Info & Tech
