HUTCHMED says AstraZeneca files US NDA for ORPATHYS, TAGRISSO

• The filing covers patients with locally advanced or metastatic NSCLC whose tumors have MET overexpression or amplification.
• The NDA is supported by the global SAFFRON Phase III trial.
• HUTCHMED said SAFFRON showed statistically significant and clinically meaningful gains in progression-free survival and overall survival.

AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration for ORPATHYS plus TAGRISSO in locally advanced or metastatic non-small cell lung cancer with MET overexpression or amplification. The filing covers patients whose disease progressed on or after EGFR tyrosine kinase inhibitor therapy.

HUTCHMED says AstraZeneca files US NDA for ORPATHYS, TAGRISSO

HUTCHMED said the application is supported by the global SAFFRON Phase III trial. It said the study showed statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in patients who progressed on TAGRISSO.

The company said the safety profile was consistent with the known profiles of each medicine and that there were no new safety concerns. It said the results will be presented in a Presidential Symposium at the European Society for Medical Oncology Congress 2026.

HUTCHMED's acting chief executive officer and chief financial officer, Johnny Cheng, said the filing is an important step toward potentially bringing the combination to patients in the US. He said the success of SAFFRON reflects the long-standing collaboration between HUTCHMED and AstraZeneca.

The company said ORPATHYS is being jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.

HUTCHMED also said SAFFRON built on evidence from the SACHI Phase III and SAVANNAH Phase II trials.