FDA Grants Priority Review to Dizal's Sunvozertinib for EGFR Exon20 Insertion-Positive NSCLC
Key Insights
The FDA has granted priority review to sunvozertinib for NSCLC (search) with EGFR (search) exon 20 insertion mutations after platinum-based chemotherapy.
Sunvozertinib's NDA is based on the pivotal WU-KONG1 Part B study, which demonstrated statistically significant clinical benefits.
If approved, sunvozertinib would be the first oral small molecule drug approved in the U.S. or Europe for this indication, offering a convenient and safe treatment option.
Dizal (search)'s sunvozertinib, an oral EGFR (search) inhibitor, has been granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC (search)) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. This decision underscores the potential of sunvozertinib to address a critical unmet need in patients with this specific genetic alteration. The FDA grants priority review to drugs that, if approved, would represent a significant improvement in safety or effectiveness over existing treatments for a serious disease.
The New Drug Application (NDA) for sunvozertinib is supported by efficacy and safety results from the multinational pivotal WU-KONG1 Part B study. Data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated statistically significant clinical benefits in relapsed or refractory NSCLC (search) patients with EGFR exon20ins (search) from Asia, Europe, North America, and South America.
Clinical Significance of Sunvozertinib
"Patients with EGFR exon20ins (search) NSCLC (search) face a poor prognosis and limited treatment options," said Xiaolin Zhang, PhD, CEO of Dizal (search). "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."
Regulatory Landscape and Prior Approvals
Currently, no small molecule drug has been approved in the U.S. or Europe to treat this serious disease. In 2023, sunvozertinib received accelerated approval from the National Medical Products Administration (NMPA) of China, making it the world's first and only oral treatment for NSCLC (search) patients with EGFR exon20ins (search). This approval was based on the results of the WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins.
About Sunvozertinib
Sunvozertinib (DZD9008) is an irreversible EGFR (search) inhibitor discovered by Dizal (search) scientists, targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. It has also demonstrated encouraging anti-tumor activity in NSCLC (search) patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Clinical data indicates that sunvozertinib has a well-tolerated and manageable safety profile, with most drug-related treatment-emergent adverse events (TEAEs) being Grade 1/2 in nature and clinically manageable.
Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC (search) patients with EGFR exon20ins (search). Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.