HUTCHMED and AstraZeneca have submitted an NDA with the US FDA for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) to treat locally advanced or metastatic non-small cell lung cancer (NSCLC), where tumours have MET overexpression, a failed epidermal growth factor recepetor (EGFR) and tyrosine kinase inhibitor (TKI) therapy.

The NDA is backed up with the SAFFRON Phase 3 study data, which showed ORPATHYS plus TAGRISSO showed a statistically significant and clinically meaningful improvement in progression free survival and overall survival.

Johnny Cheng, acting CEO and CFO of HUTCHMED noted that the filing is an important step in bringing this combination therapy to US patients, following its approval in China in June 2025.