NEW YORK – China's National Medical Products Administration (NMPA) on Wednesday approved Dizal Pharmaceutical's sunvozertinib for previously treated, advanced non-small cell lung cancer patients whose tumors harbor EGFR exon 20 insertion mutations.
Chinese regulators approved the EGFR inhibitor based on the results from the Phase II WU-KONG6 trial, in which Dizal evaluated sunvozertinib in NSCLC patients with EGFR exon 20 insertion mutations who previously received platinum-based chemotherapy. Out of 97 patients who received the recommended Phase II dose of sunvozertinib, the confirmed overall response rate was 60.8 percent, and the drug's safety profile was similar to other EGFR-targeting agents.
"The commercial launch of sunvozertinib represents a significant milestone for Dizal, underscoring our capabilities from research and development to commercialization," Dizal CEO Xiaolin Zhang said in a statement. "Moving forward, we will accelerate our efforts to achieve profitability and ensure the rapid accessibility of Dizal's innovative therapies to patients in China and worldwide."
Outside of China, Dizal is evaluating sunvozertinib in Phase II clinical trials in the US, the EU, Japan, Australia, and South Korea, among other regions. Last year, the US Food and Drug Administration granted breakthrough therapy designation to sunvozertinib for the same indication that is now approved in China.
Less than 1 percent of NSCLC patients harbor EGFR exon 20 insertion mutations in their tumors. Dizal is studying sunvozertinib as both a first- and second-line therapy for this subset of NSCLC patients. The firm has designed the drug to overcome resistance to third-generation EGFR tyrosine kinase inhibitors.