Dizal Reports the Regulatory Submission of Sunvozertinib to the US FDA for Treating R/R Non-Small Cell Lung Cancer
Shots:
- Dizal has submitted the NDA application of sunvozertinib to the US FDA for treating locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in patients whose disease has progressed after Pt-based CT
- NDA was based on the WU-KONG1 part B trial assessing the safety & efficacy of sunvozertinib in the above population from Asia, EU, North & South America which achieved its 1EP showing a significant ORR and a favorable safety. Results were highlighted at ASCO 2024
- Sunvozertinib previously received accelerated approval in China and BTDs from both the US FDA and China CDE for treating this mutation in NSCLC
Ref: Dizal | Image: Dizal
Related News:- Dizal’s Sunvozertinib Receives the NMPA’s Breakthrough Therapy Designation as a 1L Treatment of NSCLC with EGFR Mutations
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
