AstraZeneca files for US FDA approval of HUTCHMED lung cancer drug combination (updated)
UPDATE 1-AstraZeneca files for US FDA approval of HUTCHMED lung cancer drug combination Updates with details and context
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.
(Reporting by Roshan Thomas in Bengaluru; Editing by Subhranshu Sahu and Sherry Jacob-Phillips)
((Roshan.Thomas@thomsonreuters.com;))
Recent news on HUTCHMED (China)
See all newsSovleplenib Granted FDA Orphan Drug Designation
Brief: Hutchmed (China) Says FDA Grants Orphan Drug Designation To Sovleplenib For Autoimmune Hemolytic Anemia
Regulatory Filings Accepted for Review
Brief: HUTCHMED (China) Says Regulatory Filings For Orpathys Plus Tagrisso Accepted For Review In Europe And Japan
US FDA Grants Sovleplenib Orphan Drug Designation