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AstraZeneca submits FDA application for ORPATHYS plus TAGRISSO in non-small cell lung cancer
HCMHUTCHMED (China) Ltd
HUTCHMED (China) Limited announced that its partner AstraZeneca submitted a New Drug Application to the US FDA for ORPATHYS (savolitinib) plus TAGRISSO (osimertinib). The application seeks approval for this all-oral combination therapy in patients with locally advanced or metastatic non-small cell lung cancer whose tumors have MET overexpression or amplification and who progressed on EGFR tyrosine kinase inhibitor therapy. The filing is supported by the global SAFFRON Phase III trial, which demonstrated statistically significant improvements in progression-free and overall survival compared to chemotherapy. HUTCHMED operates as an innovative biopharmaceutical company focused on the discovery and commercialization of targeted cancer therapies.