AstraZeneca and HUTCHMED have submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Orpathys (savolitinib) in combination with Tagrisso (osimertinib). The application seeks approval to treat patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The submission is supported by results from the global Phase III SAFFRON trial. The combination showed statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with standard chemotherapy.
The proposed treatment is for patients whose tumors have MET overexpression or amplification, a common mechanism of resistance to EGFR-targeted therapies. The all-oral, chemotherapy-free combination aims to address an unmet need in a patient population with a poor prognosis.
The combination’s safety profile was consistent with the known profiles of each medicine. AstraZeneca and HUTCHMED jointly developed Orpathys, which AstraZeneca commercializes.