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

By Reuters News

Sept 29 (Reuters) - HUTCHMED (China) 0013.HK said on Tuesday that Anglo-Swedish drugmaker AstraZeneca AZN.L 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.

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