HUTCHMED Advances Savolitinib Combo in EU, Japan
Regulators in Europe and Japan have accepted filings for savolitinib plus osimertinib in MET-driven EGFR-mutated lung cancer.
Updated on Nov. 2, 2026 in Cancer
The European Medicines Agency validated and accepted a marketing authorization application for savolitinib plus osimertinib, and Japan's Ministry of Health, Labour and Welfare accepted a new drug application for the same combination. The regimen was tested in MET-driven, EGFR-mutated non-small cell lung cancer after disease progression on osimertinib.
Why it matters
MET overexpression or amplification is a common mechanism of resistance to third-generation EGFR inhibitors, so the combination targets a documented route by which patients stop responding. The SAFFRON trial results suggest a possible option for patients whose disease has progressed on current osimertinib therapy.
In the 338-patient SAFFRON phase 3 trial, 12-month progression-free survival was 36% for the combination versus 10% for chemotherapy, with 7% of combination-arm patients experiencing fatal adverse effects. Whether the FDA will approve the regimen remains undetermined pending review of the submitted application.
The players
HUTCHMED
HUTCHMED is a biopharmaceutical company that develops and commercializes targeted cancer therapies, including savolitinib.
European Medicines Agency
The European Medicines Agency is the European Union body responsible for the scientific evaluation and authorization of medicines.
Ministry of Health, Labour and Welfare
Japan's Ministry of Health, Labour and Welfare is the national government agency that oversees public health and reviews drug applications in Japan.
The details
SAFFRON was an international, open-label, randomized phase 3 trial of patients whose disease progressed during first- or second-line osimertinib. Control-arm patients received pemetrexed with carboplatin or cisplatin every 3 weeks for 4 cycles, followed by pemetrexed maintenance. Grade 3 or higher adverse effects occurred in 64% of combination-arm patients and 63% of chemotherapy-arm patients.
Timeline
September 2026: New drug application submitted to the FDA for the regimen.
October 25, 2026: SAFFRON results published in the New England Journal of Medicine.
November 1, 2026: HUTCHMED announced EU and Japan regulatory filings accepted.
Health Landscape
The regimen builds on osimertinib, the third-generation EGFR inhibitor now used as a standard therapy for EGFR-mutated lung cancer, and targets MET-driven resistance that limits its long-term benefit. Regulatory submissions in Europe, Japan and the United States position the combination as a potential second-line strategy for patients who progress on osimertinib.
For patients with MET-driven EGFR-mutated lung cancer whose disease has progressed on osimertinib, approval would add a new treatment option. Patients and clinicians should weigh the higher rate of fatal adverse effects seen in the combination arm when considering the regimen once it becomes available.
The takeaway
The SAFFRON results show a meaningful progression-free survival gain for a resistance-driven subgroup, but the trial's fatal adverse event rate is a key factor patients and clinicians will need to weigh as regulators review the filings.
What happens next
The FDA's review of the September 2026 new drug application for the regimen is pending, and no decision date has been provided.
Further reading
Explore more on Cancer for background on targeted therapies and lung cancer treatment.
Source note: This article includes information reported by OncLive.
