Fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins
This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. It follows the grant by the U.S. Food and Drug Administration (FDA) for the first-line setting in April this year. Sunvozertinib was previously granted BTDs by both the
BTD procedures in the US and
“The total of four Breakthrough Therapy Designations by both the
The CDE granted the BTD based on results from the pooled analysis of the global multi-center phase I/II study (WU-KONG1) and the phase II study (WU-KONG15) focused on patients from
Currently, sunvozertinib is being evaluated in the WU-KONG28 study, a phase III, multinational, randomized study to compare sunvozertinib vs. platinum doublet chemotherapies in treatment naive patients globally.
NSCLC with EGFR exon20ins are difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. In some parts of the world, an antibody with platinum containing chemotherapies is the only treatment option in the first line setting.
Sunvozertinib was approved in
References:
[1]
[2] Bazhenova L, et al.
[3] James Chih-Hsin Yang,et al. 2024ASCO #8513.
About sunvozertinib (
Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In
Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were 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 patients with EGFR exon20ins.
Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery (NASDAQ:) (IF:39.397) and The Lancet Respiratory Medicine (IF: 76.2).
About Dizal
Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two leading assets in global pivotal studies, both of which have already been launched in China.
To learn more about Dizal, please visit www.dizalpharma.com, or follow us on Linkedin or Twitter.
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