(RTTNews) - HUTCHMED (HCM) announced that AstraZeneca (AZN) has submitted a New Drug Application to the U.S. FDA for ORPATHYS in combination with TAGRISSO for certain patients with advanced non-small cell lung cancer whose disease has progressed after prior EGFR-targeted treatment.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. While EGFR-targeted therapies have improved outcomes for many patients, some tumors develop resistance through MET overexpression or amplification, creating a need for additional treatment options.
The filing seeks approval of the all-oral combination for patients with locally advanced or metastatic EGFR-mutated NSCLC whose tumors have MET overexpression or amplification and who have experienced disease progression on or after EGFR tyrosine kinase inhibitor therapy.
The NDA is supported by data from the global Phase 3 SAFFRON trial. According to the companies, the study demonstrated statistically significant and clinically meaningful improvements in both progression-free survival and overall survival for patients treated with ORPATHYS plus TAGRISSO compared with platinum-based doublet chemotherapy.
The safety profile of the combination was consistent with the known profiles of the individual medicines, and no new safety concerns were identified during the study.
ORPATHYS is being jointly developed by HUTCHMED and AstraZeneca. The treatment has already received approval in China based on results from the Phase 3 SACHI study, while the U.S. filing also builds on data from the Phase 2 SAVANNAH trial.
Detailed results from the Phase 3 SAFFRON study are scheduled to be presented at the European Society for Medical Oncology (ESMO) Congress 2026. The FDA will now review the NDA and determine whether to accept the application for formal review.
HCM has traded between $9.77 and $16.40 over the past year. The stock closed Monday's trading at $14.13, up 1.36%. During after-hours trading, the stock is at $14.42, up 2.05%.