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News
A new drug application has been submitted to the FDA for the combination of savolitinib and osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC) whose tumors have developed MET-driven resistance after prior EGFR-targeted therapy. The application is backed by the phase 3 SAFFRON trial, which showed the all-oral combo significantly improved both progression-free and overall survival versus chemotherapy. Full trial data are expected at the 2026 ESMO Congress.
AstraZeneca and Hutchmed have submitted a new drug application (NDA) to the FDA for savolitinib (Orpathys) plus osimertinib (Tagrisso) — an all-oral combination targeting a common and difficult resistance mechanism in EGFR-mutated non-small cell lung cancer (NSCLC). The application covers patients with locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed on or after EGFR TKI therapy.
The submission is anchored by the global phase 3 SAFFRON trial, which enrolled 338 patients across 29 countries and showed statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared to platinum-based doublet chemotherapy. Supporting data also come from the phase 3 SACHI trial conducted in China, which showed a striking PFS benefit for the combination. The combo is already approved in China and has received temporary authorization in Switzerland.
By the Numbers:
Why it matters: MET-driven resistance is one of the most common reasons EGFR-targeted therapies stop working, and until now, chemotherapy has been the main fallback. If approved, this all-oral regimen could offer a more effective, targeted option for a significant subset of lung cancer patients facing disease progression.
