AstraZeneca has submitted a New Drug Application to the U.S. Food and Drug Administration for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer whose tumors show MET overexpression or amplification after progression on an EGFR-TKI. The filing, announced by HUTCHMED (China) Limited on Sept. 28, 2026, is supported by the global Phase III SAFFRON trial, which reported statistically significant and clinically meaningful improvements in progression-free survival and overall survival versus doublet platinum-based chemotherapy. The combination had no new safety concerns, and results are scheduled for presentation at a Presidential Symposium during the 2026 ESMO Congress. Savolitinib is a selective MET TKI (targeted drug blocking the MET cancer pathway), while TAGRISSO is a third-generation EGFR inhibitor. The combination is already approved in China based on the SACHI Phase III trial and has temporary authorization in Switzerland based on SAVANNAH Phase II data.