HUTCHMED says AstraZeneca files US NDA for ORPATHYS plus TAGRISSO

HUTCHMED said AstraZeneca has submitted a New Drug Application to the US Food and Drug Administration for ORPATHYS plus TAGRISSO for patients with locally advanced or metastatic non-small cell lung cancer whose tumours have MET overexpression or amplification and whose disease progressed on or after an epidermal growth factor receptor tyrosine kinase inhibitor therapy.

The filing is supported by the global SAFFRON Phase III trial, which showed the combination delivered a 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.

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

Johnny Cheng, acting chief executive officer and chief financial officer of HUTCHMED, said the filing is an important step toward potentially bringing ORPATHYS plus TAGRISSO to patients in the US, after its approval in China based on the SACHI Phase III trial. He said the success of SAFFRON reflects the collaboration between HUTCHMED and AstraZeneca in addressing MET-driven progression in EGFR-mutated lung cancer, and that the company remains committed to supporting the regulatory review and making the biomarker-directed, chemotherapy-free oral combination available to eligible patients.

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