HUTCHMED: EU, Japan Accept Review of ORPATHYS® Plus TAGRISSO® for Lung Cancer
HUTCHMED announced that regulatory filings for ORPATHYS® (savolitinib) in combination with TAGRISSO® (osimertinib) have been accepted for review by the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare (MHLW). These filings seek approval for the treatment of patients with MET-driven EGFR-mutated non-small cell lung cancer (NSCLC) who have progressed on EGFR-TKI therapy. The submissions are supported by positive results from the SAFFRON global Phase III trial, which demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. This marks significant global regulatory progress following the US FDA submission in September 2026.
Key Highlights
- HUTCHMED announces regulatory filings for ORPATHYS® plus TAGRISSO® accepted for review in Europe and Japan.
- Filings are for treatment of MET-driven EGFR-mutated lung cancer in patients progressing on EGFR-TKI therapy.
- Regulatory submissions follow US FDA new drug application submission in September 2026.
- SAFFRON global Phase III data supports filings, showing significant PFS and OS improvements.
- ORPATHYS® plus TAGRISSO® reduced risk of disease progression or death by 45% vs chemotherapy (PFS HR 0.55).
- Median PFS was 7.6 months for ORPATHYS® plus TAGRISSO® vs 5.4 months for comparator.
- Overall survival showed a 32% reduction in risk of death (OS HR 0.68) with median OS extended by 4.9 months.
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