U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
The FDA accepted the New Drug Application for zipalertinib for the treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. The submission is supported by data from the Phase 2b REZILIENT1 trial, which demonstrated a confirmed objective response rate of 35% and a median duration of response of 8.8 months in the primary efficacy population.
Key figures
- Drug Name
- Zipalertinib (CLN-081/TAS6417)
- Phase Of Trial
- Phase 2b
- Pdufa date
- February 27, 2027
- Primary pop orr
- 35%
- Primary pop mdor
- 8.8 months
- Platinum only orr
- 40%
AI analysis
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