Hutchmed has confirmed that regulatory filings for Orpathys plus Tagrisso have been accepted for review in Europe and Japan.
The submissions aim to expand access to the targeted combination therapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumours show MET overexpression or amplification and who have progressed following EGFR‑TKI treatment.
In Europe, the EMA has validated and accepted the marketing authorisation application submitted by AstraZeneca. The filing seeks approval for patients whose disease has progressed on or after an EGFR‑TKI therapy.
In Japan, AstraZeneca has submitted a new drug application to the MHLW, which has also been accepted for review. The application covers patients with unresectable, advanced or recurrent disease who have MET overexpression or amplification and who have progressed following EGFR‑TKI therapy.
These steps follow the NDA submission to the FDA in September 2026 and mark further global regulatory momentum for the combination therapy.
The filings are supported by positive data from the global phase 3 Saffron trial. The results were presented at the ESMO Congress 2026 Presidential Symposium and published in The New England Journal of Medicine.
Orpathys plus Tagrisso delivered statistically significant and clinically meaningful improvements in progression‑free survival and overall survival versus doublet platinum‑based chemotherapy in patients who had progressed on Tagrisso. The combination reduced the risk of disease progression or death by 45% compared to chemotherapy. Median progression‑free survival was 7.6 months versus 5.4 months for the comparator arm.
Results for overall survival showed a 32% reduction in the risk of death versus chemotherapy. Median overall survival was extended by 4.9 months, reaching 17.8 months versus 12.9 months. The safety profile was consistent with known data, with no new concerns reported.
Orpathys is jointly developed by AstraZeneca and Hutchmed and is commercialised by AstraZeneca.
