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Savolitinib Plus Osimertinib NDA Submitted to FDA for MET-Driven, EGFR-Mutated NSCLC ...
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Fusion42 · 29 September 2026 · Fusion42 review
AstraZeneca and Hutchmed have submitted an NDA to the FDA for the combination of savolitinib and osimertinib to treat MET-driven, EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR TKI therapy. This is supported by phase 3 SAFFRON trial data showing improved progression-free and overall survival versus chemotherapy.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 29 Sep 2026 and 30 Sep 2026.
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You must prepare for a new standard in treating EGFR-mutated NSCLC with MET-driven resistance as FDA approval looms, changing competitive and clinical strategies. Expect patient demand shifts and possible trial redesigns to include this combination.
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2 sources · first reported 29 Sep 2026 · latest 30 Sep 2026
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