Conclusions
1 evidence topic · 4 sources
Summary
Zipalertinib remains investigational. The NDA concerns treatment after platinum-based chemotherapy, with or without amivantamab; the stated FDA target action date is February 27, 2027. The first-line REZILIENT3 combination results address a different treatment setting. At its interim OS analysis, event maturity was 30% and the hazard ratio was 0.72 with a 95% CI of 0.42 to 1.23, so an OS benefit is not established by that analysis.