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

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)

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