Dizal has received approval from China’s National Medical Products Administration (NMPA) for sunvozertinib to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
Sunvozertinib is intended for patients whose disease has advanced on or after platinum-based chemotherapy.
Discovered by Dizal scientists, sunvozertinib is an irreversible EGFR inhibitor designed to target a range of EGFR mutations with wild-type EGFR selectivity.
The approval from NMPA was based on the data from the pivotal study, WU-KONG6, which evaluated sunvozertinib in pretreated NSCLC patients with EGFR Exon20ins mutations.
The trial included 97 patients treated with the recommended Phase II dose of 300mg QD [four times per day].
WU-KONG6’s primary endpoint was a confirmed objective response rate (cORR). The resulting rate was 60.8%, a significant improvement on current treatment options.
Dizal CEO and chairman Xiaolin Zhang stated: “Sunvozertinib represents a groundbreaking achievement as the first Chinese innovative drug approved for EGFR Exon20ins NSCLC, showcasing Dizal’s remarkable efficiency and unwavering commitment to innovation.
“Our achievement of obtaining NDA approval in less than four years from enrolling the first patient sets an unprecedented benchmark for the rapid development of targeted lung cancer treatments.
“Furthermore, the commercial launch of sunvozertinib represents a significant milestone for Dizal, underscoring our capabilities from research and development to commercialisation.”
NSCLC is the most widespread cancer in China, with the highest rates of both incidence and mortality.