HUTCHMED said Tuesday that partner AstraZeneca (AZN) has submitted a New Drug Application to the US Food and Drug Administration for the lung-cancer fighting drugs Orpathys plus Tagrisso.

The drug combination treats metastatic non-small cell lung cancers, the tumors of which have over-expression or amplification of proteins on their surfaces, in patients who had disease progression on or after an epidermal growth factor receptor tyrosine kinase inhibitor therapy, said Hutchmed.

The drug combination is an oral, biomarker-directed, chemotherapy-free treatment for non-small cell lung cancers, the validity of which is supported by Saffron, a completed global phase III trial, said Hutchmed.

The Saffron trial showed the drug combination demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in patients who progressed on treatment with Tagrisso alone, said Hutchmed.

The Orpathys plus Tagrisso drug combination has already been approved for certain uses in China, said Hutchmed.

Detailed clinical results from the Saffron trial will be presented during European Society for Medical Oncology Congress 2026, in late October, said Hutchmed.