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AstraZeneca files for US FDA approval of HUTCHMED lung cancer drug combination

By Thomson Reuters Sep 28, 2026 | 7:18 PM

Sept 29 (Reuters) – HUTCHMED (China) said on Tuesday that Anglo-Swedish drugmaker AstraZeneca had ​applied to the ‌US Food and Drug Administration for approval of the ORPATHYS-TAGRISSO combination to treat patients with ‌advanced ​lung cancer.

ORPATHYS ⁠is being jointly ⁠developed by AstraZeneca and HUTCHMED and is commercialised by AstraZeneca.

Here are some details:

• ​The company said the combination extended progression-free ⁠survival and ⁠improved overall survival compared ​with chemotherapy.

• The treatment ​targets patients whose cancer progressed ‌following prior EGFR-targeted treatment.

• EGFR refers to epidermal growth factor receptor, a ⁠protein found on the surface of cells that helps them grow ⁠and ‌divide.

• ORPATHYS has ⁠already been approved ​in ‌China based on data ​from a ⁠separate Phase III study, HUTCHMED said.

(Reporting by Roshan Thomas in Bengaluru; Editing by Subhranshu Sahu and ​Sherry Jacob-Phillips)