HUTCHMED says AstraZeneca files US NDA for Orpathys-Tagrisso lung cancer combo
HCM•AstraZeneca filed a US FDA NDA for savolitinib with osimertinib to treat MET-driven EGFR-mutated non-small cell lung cancer after EGFR-TKI progression. The filing is based on the Phase III SAFFRON trial, which met progression-free and overall survival endpoints versus platinum-doublet chemotherapy.
1. US application filed
AstraZeneca filed a US FDA NDA for savolitinib, developed with HUTCHMED, in combination with osimertinib for MET-driven EGFR-mutated non-small cell lung cancer following EGFR-TKI progression. The proposed oral regimen targets tumors with MET overexpression or amplification, and the filing relies on the Phase III SAFFRON trial, which met progression-free survival and overall survival endpoints versus platinum-doublet chemotherapy.
