HUTCHMED's Orpathys-Tagrisso filings for lung cancer accepted in Europe and Japan
The regulatory filings follow an FDA submission in September 2026 and build on SAFFRON Phase III data showing a 45% cut in progression risk and nearly five months of added survival.
HUTCHMED announced on November 2, 2026 that regulatory filings for ORPATHYS® (savolitinib) combined with TAGRISSO® (osimertinib) have cleared an initial review hurdle in two new markets. In Europe, the European Medicines Agency validated and accepted for review AstraZeneca's Marketing Authorization Application seeking approval of the combination for patients with locally advanced or metastatic non-small cell lung cancer whose tumors show MET overexpression or amplification and who progressed after EGFR tyrosine kinase inhibitor therapy.1 In Japan, AstraZeneca filed a New Drug Application with the Ministry of Health, Labour and Welfare, which has also been accepted for review, covering patients with unresectable, advanced or recurrent NSCLC with the same MET aberrations following disease progression on EGFR-TKI therapy.1
These Europe and Japan filings follow the NDA HUTCHMED submitted to the FDA for the same combination in September 2026.1
The filings rest on the SAFFRON global Phase III trial, whose results were presented at the ESMO Presidential Symposium and published simultaneously in The New England Journal of Medicine. The combination cut the risk of disease progression or death by 45% versus chemotherapy, with a hazard ratio of 0.55, and produced a median progression-free survival of 7.6 months compared with 5.4 months for chemotherapy.1 On the key secondary endpoint, the combination reduced the risk of death by 32% relative to chemotherapy and extended median overall survival to 17.8 months versus 12.9 months, a gain of 4.9 months.1 The safety profile matched what was already known for each drug, with no new safety concerns identified.1
The combination therapy titled "ORPATHYS® in combination with TAGRISSO®" already has approval in China, covering patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy, based on the SACHI Phase III trial.1 ORPATHYS® is jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.