Bristol Myers Squibb says its investigational radiopharmaceutical RYZ101 met the primary progression-free survival goal in the Phase 3 ACTION-1 trial for certain advanced neuroendocrine tumours.
The trial is studying RYZ101 in patients with SSTR-positive gastroenteropancreatic neuroendocrine tumours whose disease progressed after lutetium-177 treatment. The company reported a statistically significant and clinically meaningful improvement in progression-free survival based on blinded independent central review.
What is RYZ101?
RYZ101 links the targeted molecule DOTATATE to Actinium-225. The radioactive alpha particle is designed to deliver high-energy, short-range damage to cancer cells that carry the target.
What has not been published yet?
Bristol Myers has not yet released the median progression-free survival, hazard ratio, confidence interval or full safety tables in the topline announcement. Detailed data are expected at a future medical meeting. Overall-survival follow-up is continuing.
RYZ101 received FDA Orphan Drug Designation in August 2026, but that is not marketing approval. The company still needs a complete New Drug Application, FDA review and a decision. Patients should not change treatment based on a press release; consult their oncology team.
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Sources: Bristol Myers announcement · FDA NDA process · FDA drug development process