HUTCHMED 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.
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Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.1 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.
Approximately 75% of NSCLC patients are diagnosed with advanced disease.
Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.
MET is a tyrosine kinase receptor that has an essential role in normal cell development.7 MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.
An estimated 34% of tumors will develop high levels of MET overexpression or amplification after progression on a third-generation EGFR TKI.
