HUTCHMED, AstraZeneca file US NDA for Orpathys plus Tagrisso in MET-driven lung cancer

AstraZeneca submitted a New Drug Application to the US Food and Drug Administration on September 29, 2026 for Orpathys (savolitinib) plus Tagrisso (osimertinib), seeking a biomarker-directed, all-oral treatment option for patients whose tumors have MET overexpression or amplification, after progression on an EGFR-TKI therapy.¹ HUTCHMED (China) Limited announced the filing.

The NDA is supported by the global SAFFRON Phase III trial, which showed the combination demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in patients who progressed on treatment with Tagrisso.¹ The safety profile was consistent with the known profiles of each medicine, with no new safety concerns.¹ Full results will be presented in a Presidential Symposium at the upcoming ESMO Congress 2026.¹

The trial design: SAFFRON was a randomized, open-label, multi-center, global Phase III trial studying Orpathys (300 mg twice daily) added to Tagrisso (80 mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line Tagrisso treatment.¹ The trial enrolled patients at 230 centers across 29 countries.¹

Orpathys is being jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.¹ The combination is already approved in China: Orpathys in combination with Tagrisso is approved in China for 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 It also received temporary authorization in Switzerland for the same setting, based on results from the global SAVANNAH Phase II trial.¹