A lung cancer treatment can work for a time, then the tumour finds another route to grow. A new US regulatory filing aims at one such escape route.
On 28 September 2026, HUTCHMED said AstraZeneca had submitted a New Drug Application to the US Food and Drug Administration for savolitinib plus osimertinib. The proposed use is for people with advanced EGFR-mutated non-small-cell lung cancer whose disease has progressed after an EGFR-targeted drug and whose tumours show high MET activity. A submission begins a review; it is not an FDA approval. HUTCHMED announcement
Why target two signals?
EGFR and MET are proteins that can send growth instructions into a cell. Osimertinib blocks abnormal EGFR signalling. Some tumours that initially respond develop extra MET activity, allowing growth signals to continue by another route. Savolitinib targets MET. The combination attempts to block both paths in tumours identified by a biomarker test.
That biomarker matters. This is a proposal for a defined group with MET overexpression or amplification, not every person with lung cancer. It also concerns disease after earlier EGFR treatment, rather than an initial treatment for all patients.
What the trial has shown so far
The global Phase III SAFFRON trial randomly assigned 338 patients to the two oral targeted drugs or a platinum-based chemotherapy combination after progression on osimertinib. HUTCHMED reports statistically significant improvements in both progression-free survival, the time before cancer worsens, and overall survival, the time patients live after entering the study. It says the safety findings matched the known drug profiles. Trial and filing details
The announcement does not yet give the median survival times, the size of the difference, or the full adverse-event tables. The company says it will present the results at the 2026 European Society for Medical Oncology congress. Those details will help readers judge the clinical benefit against side effects and the existing chemotherapy option.
The combination has been approved in China on the basis of a different Phase III study, SACHI, and has temporary authorisation in Switzerland for a defined population. Neither decision determines the outcome of the US review. Regulatory context
The news is a substantial clinical and regulatory step for a resistance mechanism that has frustrated targeted treatment. The next tests are the complete SAFFRON data and the FDA’s assessment of benefit and risk.
Featured image: representative image by Logan Gutierrez / Unsplash. It does not depict the specific study, facility or equipment described.
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