Dizal Submits NDA to FDA for Sunvozertinib in EGFR Exon20ins NSCLC
Key Insights
Dizal (search) has submitted a New Drug Application (NDA) to the FDA for sunvozertinib, targeting non-small cell lung cancer (search) (NSCLC) with EGFR (search) exon 20 insertion mutations.
The NDA is supported by the WU-KONG1 Part B study, which demonstrated a statistically significant and clinically meaningful objective response rate (ORR) in relapsed or refractory patients.
Sunvozertinib has already received accelerated approval in China for the same indication and Breakthrough Therapy Designations from both the U.S. FDA and China's CDE.
Dizal (search), a biopharmaceutical company, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sunvozertinib. The application seeks approval for the treatment of locally advanced or metastatic non-small cell lung cancer (search) (NSCLC) patients harboring epidermal growth factor receptor (EGFR (search)) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy.
Clinical Trial Data
The NDA submission is backed by data from the WU-KONG1 Part B study, a multinational pivotal trial evaluating the efficacy and safety of sunvozertinib in relapsed or refractory EGFR (search) exon20ins NSCLC patients across Asia, Europe, North America, and South America. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate (ORR) as assessed by an independent review committee (IRC). The full data were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Regulatory Status and Previous Approvals
Sunvozertinib has already received accelerated approval in China, making it the first and only oral drug approved for NSCLC patients with EGFR (search) exon20ins in that region. It has also been granted Breakthrough Therapy Designations (BTDs) by both the U.S. FDA and the China Center for Drug Evaluation (CDE) for the same indication.
Significance of Sunvozertinib
"We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR (search) exon20ins NSCLC," said Xiaolin Zhang, PhD, CEO of Dizal (search). "The filing for approval of sunvozertinib marks Dizal’s first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application."
NSCLC and EGFR Exon20ins Mutations
Lung cancer remains the leading cause of cancer incidence and mortality worldwide, with NSCLC accounting for approximately 80%-85% of all lung cancer cases. Patients with NSCLC harboring EGFR (search) exon20ins mutations typically face a poorer prognosis compared to those with other EGFR sensitizing mutations. Sunvozertinib, designed with an innovative molecular structure, aims to provide enhanced efficacy, safety, and ease of administration for these patients.
About Sunvozertinib
Sunvozertinib is an irreversible EGFR (search) inhibitor developed by Dizal (search), targeting a broad spectrum of EGFR mutations with selectivity for wild-type EGFR. In August 2023, it received approval from China's NMPA for treating advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies, based on the WU-KONG6 study, where the confirmed overall response rate (cORR) reached 60.8% as assessed by the Independent Review Committee (IRC). The drug has also shown encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.
Ongoing Clinical Trials
Two global pivotal studies are currently underway in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR (search) exon20ins.