Dizal's recent announcement regarding the FDA's granting of Breakthrough Therapy
The approval stems from compelling data from the global phase I/II study, WU-KONG1, showcasing sunvozertinib's efficacy as a first-line treatment. Notably, at the 2023 ESMO conference.
Dizal presented data demonstrating sunvozertinib's impressive objective response rate (cORR) of 78.6% and a median progression-free survival (mPFS) of 12.4 months when used as a monotherapy.
Designation (BTD) to sunvozertinib signifies a significant advancement in the treatment of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations, particularly in advanced stages.
Previously, sunvozertinib received BTDs from both the FDA and the China Center for Drug Evaluation (CDE) for treating relapsed or refractory patients.
Following its approval in China in 2023 for those who had failed first-line treatment, NDA submissions for U.S. and EU approvals in the same context are anticipated later in 2024.
The potential to transform the treatment landscape for EGFR exon20ins NSCLC. The drug's oral administration and safety profile offer distinct advantages over traditional chemotherapies.
With the completion of enrollment for the global pivotal study in relapsed and refractory settings (WU-KONG1 PART B), Dizal is poised to present the study results at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Additionally, a randomized global phase III study in the first-line setting (WU-KONG28) is underway, underscoring the commitment to advancing treatment options.
EGFR Exon20ins mutations present a formidable challenge in NSCLC treatment due to their unique characteristics. Sunvozertinib's innovative molecular structure enables it to effectively target these mutations, offering enhanced efficacy, safety, and ease of administration.
Its approval in China for previously treated NSCLC patients underscores its potential as a potent and well-tolerated therapy in this challenging patient population.
