Dizal Seeks FDA Approval for Sunvozertinib in EGFR Exon20ins NSCLC

• Dizal has submitted a New Drug Application (NDA) to the FDA for sunvozertinib, targeting locally advanced or metastatic NSCLC with EGFR exon20 insertion mutations.
• The NDA is supported by the WU-KONG1 Part B trial, which demonstrated a statistically significant and clinically meaningful objective response rate in relapsed or refractory patients.
• Sunvozertinib, an irreversible EGFR inhibitor, has already received accelerated approval in China and breakthrough therapy designations from both the FDA and China's CDE.
• A Phase III trial, WU-KONG28, is underway to compare sunvozertinib with platinum doublet chemotherapies in treatment-naive patients globally.

Dizal has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sunvozertinib, an investigational therapy for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations. These mutations are detected using an FDA-approved test.

Sunvozertinib is designed as an irreversible EGFR inhibitor with selectivity for wild-type EGFR while targeting a broad range of mutations. The NDA is based on data from the WU-KONG1 Part B multinational trial, which assessed the safety and efficacy of sunvozertinib in patients with relapsed or refractory EGFR exon20ins NSCLC across Asia, North America, South America, and Europe.

Clinical Trial Data

The WU-KONG1 Part B trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate (ORR) with sunvozertinib in the target patient population. Specific data regarding the ORR and other efficacy measures will be presented at an upcoming medical conference.

Executive Perspectives

Dizal CEO Xiaolin Zhang stated, "We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC. 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."

Regulatory Status and Ongoing Trials

Sunvozertinib received accelerated approval in China, becoming the first oral medication globally for NSCLC patients with EGFR exon20ins mutations. It also holds breakthrough therapy designations (BTDs) from the FDA (granted in April) and China’s Center for Drug Evaluation (CDE) (granted in October) for the same indication.

Currently, sunvozertinib is being evaluated in the Phase III WU-KONG28 trial, a randomized, multinational study comparing it to platinum doublet chemotherapies in treatment-naive patients on a global scale. This trial aims to further establish the efficacy and safety profile of sunvozertinib as a first-line treatment option.

Previous Approval

In August of the previous year, China’s National Medical Products Administration (NMPA) approved sunvozertinib for treating advanced NSCLC with EGFR exon20ins mutations following platinum-based chemotherapy, marking an earlier milestone in the drug's development and regulatory journey.