Hutchmed lung cancer combination accepted for review in Europe, Japan

Hutchmed said on Monday that regulators in Europe and Japan have accepted for review filings for its ORPATHYS savolitinib combined with AstraZeneca's TAGRISSO osimertinib in MET-driven, EGFR-mutated lung cancer, following a United States filing in September.

Why it matters: The acceptances put the combination into review in three major markets on Phase III data showing median survival of 17.8 months against 12.9 months on chemotherapy, in a resistance setting with no approved targeted option in most markets.

Data as of Hutchmed Form 6-K filed with the SEC on November 2, 2026 (accession 0001648257-26-000074), read in full in this run; every figure and detail comes from the company's own filing. Developing item.

Hutchmed said the European Medicines Agency has validated AstraZeneca’s marketing application for savolitinib plus osimertinib in locally advanced or metastatic non-small cell lung cancer with MET overexpression or amplification after progression on an EGFR inhibitor, and that Japan’s health ministry has accepted a new drug application for unresectable, advanced or recurrent disease in the same setting. The filings follow a United States submission in September 2026.

Both rest on the SAFFRON Phase III trial in 338 patients, presented at the ESMO Congress 2026 and published in The New England Journal of Medicine. The combination cut the risk of progression or death by 45 percent against platinum chemotherapy, with median progression-free survival of 7.6 months against 5.4 months, and cut the risk of death by 32 percent, with median overall survival of 17.8 months against 12.9 months. Hutchmed said the safety profile matched the known profiles of the two drugs, with no new concerns.

Hutchmed lung cancer combination accepted for review in Europe, Japan

Sources