FDA Grants Priority Review to New Drug Application for Sunvozertinib in NSCLC

The US Food and Drug Administration (FDA) has accepted and granted priority review to the New Drug Application (NDA) for sunvozertinib, according to an announcement from Dizal.

The oral EGFR inhibitor has been granted priority review for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with EGFR exon 20 insertion (exon20ins) mutations detected by an FDA-approved test and whose disease has progressed on or after platinum-based chemotherapy. Sunvozertinib is an irreversible EGFR inhibitor that targets “a wide spectrum of EGFR mutations with wild-type EGFR selectivity,” according to Dizal.

“This decision follows the FDA’s earlier Breakthrough Therapy Designations for sunvozertinib in treatment-naïve and relapsed or refractory settings,” Dizal officials said. “Currently, no small molecule drug has been approved in the U.S. or Europe to treat this serious disease.”

The New Drug Application submission is “supported by efficacy and safety results” from the multinational pivotal WU-KONG1 Part B study, officials said. The trial is evaluating sunvozertinib in relapsed or refractory NSCLC with EGFR exon20ins in patients from Asia, Europe, North America, and South America, with data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating “statistically significant clinical benefits,” officials said.

Xiaolin Zhang, PhD, Dizal CEO, reflected on the implications of the FDA’s move to grant priority review to the New Drug Application for sunvozertinib.

“Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options,” Dr. Zhang said in a statement. “Sunvozertinib’s Priority Review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are promising. If approved, sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins.”

Sunvozertinib has shown a “well-tolerated and manageable safety profile in the clinic,” according to Dizal officials, who explained that the most common treatment-emergent adverse events were “grade 1/2 in nature and clinically manageable.”

The oral EGFR inhibitor was previously granted accelerated approval by the National Medical Products Administration (NMPA) of China in 2023, “making it the world’s first and only oral treatment for NSCLC patients with EGFR exon20ins,” according to the announcement. The NMPA approval is based on the results of WU-KONG6 study, which was the pivotal study of sunvozertinib in patients who previously received platinum-based chemotherapy to treat NSCLC with EGFR exon20ins.

“In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins,” Dizal officials explained.

Currently, the WU-KONG1 part B study is evaluating sunvozertinib in the second line and later setting, while the WU-KONG28 study is evaluating it in the first-line setting. Both studies are global, pivotal trials evaluating the treatment in patients with NSCLC who have EGFR exon20ins.

Source: Dizal Pharmaceutical