AstraZeneca files US application for lung-cancer combination developed with HUTCHMED

HUTCHMED ($HCM) said AstraZeneca ($AZN) submitted a US new drug application for savolitinib, marketed as ORPATHYS in other jurisdictions, combined with TAGRISSO. The proposed use is MET-driven, EGFR-mutated advanced non-small-cell lung cancer after progression on an EGFR-targeted treatment. The application draws on SAFFRON, a 338-patient randomized Phase III study comparing the combination with platinum-based chemotherapy.

The filing advances the partners’ effort to address resistance to existing targeted therapy. Previously disclosed trial findings showed statistically significant improvements in progression-free and overall survival; the release does not present a new numerical efficacy readout. HUTCHMED and AstraZeneca jointly develop savolitinib, with AstraZeneca responsible for commercialization. Submission is not FDA acceptance for review or marketing approval, and the announcement provides no regulatory decision date or assurance that the requested indication will be authorized.

Sources:

• HUTCHMED GlobeNewswire release, reproduced by StockTitan