CGEM initiates NDA submission for zipalertinib plus chemotherapy
CGEN says it initiated a new drug application submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion mutation NSCLC under FDA Real-Time Oncology Review.
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11:32:00 PM UTC
SquawkNews
In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival observed to date in first-line EGFR exon20ins NSCLCAfter agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission…