Regulatory review begins for ORPATHYS plus TAGRISSO in MET-driven EGFR-mutated lung cancer in Europe and Japan

HUTCHMED and AstraZeneca have secured regulatory review acceptance in Europe and Japan for ORPATHYS (savolitinib) combined with TAGRISSO (osimertinib) to treat MET-driven EGFR-mutated non-small cell lung cancer (NSCLC). This follows a US FDA submission in September 2026 and is backed by positive Phase III SAFFRON trial results showing significant improvements in progression-free and overall survival compared to chemotherapy. The filings mark a key step toward global approval, addressing a critical need for patients with resistance to existing EGFR therapies. Approval could expand access to this targeted treatment in major markets soon.

AstraZeneca's stock price rose 7.10% to USD 186.79 on Pluang as of Nov 02, 2026 07:11 WIB. The company holds a market cap of $289.63 billion and a dividend yield of 1.72%. This positive market activity coincides with the regulatory filings acceptance for ORPATHYS plus TAGRISSO in Europe and Japan.