REZILIENT3 delivers Phase 3 PFS win and a $100M milestone, but the 2L NDA rides single-arm data to a Feb 2027 PDUFA — approvability of that filing is the first gate

Cullinan Therapeutics is a clinical-stage company developing a targeted cancer drug for non-small-cell lung cancer with EGFR exon 20 insertion mutations, a treatment not yet approved.

Zipalertinib targets EGFR exon 20 insertion mutations, a defined NSCLC subset with few approved options, and now holds two approval vectors: a 2L single-arm NDA with a February 27, 2027 PDUFA, and a first-line Phase 3 combination win (PFS 14.5 vs. 8.5 months, HR=0.50) that triggered a $100M Taiho milestone. The thesis resolves on whether FDA grants accelerated approval on the single-arm 2L data, since that is the nearer binary and the first-line NDA pathway has not yet been agreed with regulators. The structural risk is that three patient deaths in REZILIENT3 introduce a safety question the agency will weigh alongside a single-arm data package that carries inherently higher approvability uncertainty than a randomized trial.