MarketPR
(Nasdaq: CGEM) has begun the process of submitting a New Drug Application to the U.S. Food and Drug Administration for zipalertinib combined with platinum-based chemotherapy.
The company filed this application under the FDA's Real-Time Oncology Review program, which allows sponsors to share clinical data before the full application is complete.
This approach is intended to facilitate an earlier review of the drug's efficacy and safety results. The submission relies on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint.
The study showed that adding zipalertinib to chemotherapy improved median progression-free survival in a statistically significant and clinically meaningful way compared to chemotherapy alone.
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