Shots:
- The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT
- Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement in ORR & DoR. Data was presented at ASCO 2024 & published in The JCO
- Additionally, FDA has approved Thermo Fisher’s Oncomine Dx Express Test as a next-generation sequencing (NGS) CDx for Zegfrovy to identify NSCLC pts with EGFR exon20ins by delivering NGS results in ~24hrs. when it is combined with Ion Torrent Genexus Dx System
Ref: Prnewswire | Image: Dizal | Press Release
Related News:- Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC
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