AstraZeneca Seeks US FDA Approval for Lung Cancer Treatment

Published On 29 Sep, 2026
astrazeneca-seeks-us-fda-approval-for-lung-cancer-treatment

9 News HD:  AstraZeneca has applied to the US Food and Drug Administration (FDA) for approval of a new lung cancer treatment combination developed with HUTCHMED.

The application covers the use of ORPATHYS with TAGRISSO for patients with advanced lung cancer. ORPATHYS is being developed jointly by AstraZeneca and HUTCHMED, while AstraZeneca is responsible for its commercialisation.

The treatment is aimed at patients whose lung cancer has specific changes linked to the MET protein and whose disease has progressed after earlier treatment with an EGFR-targeted drug. The companies are seeking approval to provide another treatment option for this group of patients.

The US FDA will now review the application and assess the available medical and clinical data before making a decision. The submission is an important step in the companies’ efforts to expand treatment options for people living with advanced lung cancer.

AstraZeneca and HUTCHMED have been working together on ORPATHYS as part of their wider focus on developing targeted treatments for cancer. The companies will continue to await the FDA’s decision on the US application.