FDA Approves Y-90 Resin Microspheres for Patients With Unresectable Hepatocellular Carcinoma
On July 7, 2025, the US Food and Drug Administration (FDA) approved Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma. This approval was based on interim results from the DOORwaY90 trial.
In this multicenter, open-label trial, 65 patients received 513.1 Gy of Y-90 resin microspheres. Primary end points included overall response rate (ORR) and duration of response. Key secondary end points included local tumor control rate and safety.
At analysis, the best ORR was 98.5% with a best complete response rate of 92.2%. The median duration of response was 300.5 days, with 76.6% of patients achieving response within ≥ 6 months. The local tumor control rate was 100%. Adverse events were reported in 85% of patients. Serious device- or procedure-related adverse events were reported in 3 patients and most frequently included abdominal pain, radioembolization-induced liver disease, and nausea. Stable liver function was reported in > 95% of patients.
"This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results," concluded Armeen Mahvash, MD, MD Anderson Cancer Center, Houston, Texas, and coauthors.
Sources:
Sirtex Medical's SIR-Spheres® Y-90 resin microspheres receive FDA approval for the treatment of unresectable hepatocellular carcinoma. Accessed on July 7, 2025. https://www.prnewswire.com/news-releases/sirtex-medicals-sir-spheres-y-90-resin-microspheres-receive-fda-approval-for-the-treatment-of-unresectable-hepatocellular-carcinoma-302498439.html
DOORwaY90 study interim results. Accessed on July 7, 2025. https://www.sirtex.com/us/products/sir-spheres/clinical-trials/doorway90-study/doorway90-study-interim-results/
