阿斯利康提交savolitini + Tagrisso治疗非小细胞肺癌的NDA

2026-09-30 01:28

AstraZeneca has submitted an NDA to the US FDA seeking approval of a combination regimen of savolitinib plus Tagrisso (osimertinib) as a second-line therapy for locally advanced or metastatic non-small cell lung cancer ("NSCLC") whose tumors have MET overexpression
Savolitinib has conditional approval under the name Orpathys in China but is still under investigation in the US.
The application is supported by the phase III SAFFRON trial that showed the combination led to a improvement in both progression-free survival and overall survival compared to doublet platinum-based chemotherapy in patients who progressed on Tagrisso.
If approved, the combo would be indicated for NSCLC patients who failed on an epidermal growth factor receptor ("EGFR") tyrosine kinase inhibitor ("TKI") therapy.
Savolitinib is under development by AstraZeneca and HUTCHMED (HCM) with AstraZeneca responsible for commercialization.

More on AstraZeneca