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AstraZeneca PLCAZNAstraZeneca PLC

AstraZeneca files for US FDA approval of Orpathys combo

The submission covers Orpathys combined with Tagrisso for MET-driven EGFR-mutated lung cancer.

El Fondo Newsdesk
El Fondo NewsdeskAutomated market news
·1 min

AstraZeneca and HUTCHMED have submitted a New Drug Application to the U.S. Food and Drug Administration for ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib). The submission seeks approval for treating MET-driven, EGFR-mutated advanced non-small cell lung cancer after progression on previous therapy.

The regulatory filing relies on findings from the global Phase III SAFFRON trial. The study evaluated the combination therapy across 230 study centers located in 29 countries.

A total of 338 patients enrolled in the trial. In the combination treatment arm, patients received 300 mg of savolitinib twice daily along with 80 mg of osimertinib once daily.

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