AstraZeneca Files for FDA Approval of Lung Cancer Combination Therapy

Key Facts

1AstraZeneca filed an application with the US FDA for approval of the ORPATHYS-TAGRISSO combination for advanced lung cancer.

AstraZeneca filed an application with the US FDA for approval of the ORPATHYS-TAGRISSO combination for advanced lung cancer. Reuters reported that the submission seeks marketing authorization for the therapy, which was developed in collaboration with HUTCHMED (China) Limited.

AZN closed at $166.15 on September 28, 2026, while HCM closed at $13.94 on September 25, 2026. The formal filing represents a critical regulatory milestone, indicating progress toward the commercialization of the new oncology treatment in the United States.