AstraZeneca, Hutchmed Seek US FDA Nod for Lung Cancer Combination Therapy

MT Newswires · 2d ago
12:35 AM EDT, 09/29/2026 (MT Newswires) -- Drugmaker AstraZeneca (AZN.L, AZN.ST) filed a new drug application with the US Food and Drug Administration for Orpathys plus Tagrisso to treat locally advanced or metastatic non-small cell lung cancer. The combination is intended for patients whose tumors have MET overexpression or amplification and have progressed on or after epidermal growth factor receptor tyrosine kinase inhibitor therapy, according to a Tuesday release. Orpathys is being jointly developed by AstraZeneca and Hutchmed (China) (HCM.L) and is commercialized by AstraZeneca. The application is backed by data from the Saffron phase 3 trial, in which the combination showed statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with doublet platinum-based chemotherapy.