Cullinan Accelerates Lung Cancer Fight: FDA Review Underway for Zipalertinib Combo

Cullinan Therapeutics just kicked off a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for its promising lung cancer drug, zipalertinib, for use alongside platinum-based chemotherapy. This crucial step on October 1, 2026, aims to bring a new first-line treatment option to patients battling locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR exon 20 insertion mutations, a historically tough-to-treat form of the disease. The FDA is fast-tracking the review under its Real-Time Oncology Review (RTOR) program, signaling the potential significance of this therapy. The submission is backed by robust data from the Phase 3 REZILIENT3 trial, which demonstrated a significant improvement in patient outcomes. Results, recently highlighted at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC), showed that combining zipalertinib with chemotherapy extended median progression-free survival (PFS) by a remarkable six months compared to chemotherapy alone – from 8.5 months to 14.5 months. This kind of survival benefit is a big deal for patients with these challenging mutations, where treatment options have been limited. While a separate NDA for zipalertinib as a single therapy for previously treated patients is already under FDA review with a decision expected by February 27, 2027, this new combination filing positions Cullinan to potentially reshape the initial treatment landscape for this patient group. The expedited RTOR pathway means we could see an FDA decision sooner, and the medical community will be keenly watching how this drug competes with other emerging therapies in this rapidly evolving field.