FDA Approves Y-90 Resin Microspheres for Unrespectable Hepatocellular Carcinoma

The FDA has approved Y-90 resin microspheres (SIR-Spheres; Sirtex Medical), a radioembolization therapy for the treatment of unresectable hepatocellular carcinoma (HCC), which is marked as the most common form of liver cancer in adults residing in the US. The company noted that approval makes Y-90 resin microspheres the only granted treatment for both metastatic colorectal cancer (mCRC) of the liver and HCC.¹

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Hepatocellular Carcinoma

HCC is a type of cancer that begins as a growth of cells in the liver, called hepatocytes, and often occurs in individuals with chronic liver conditions like cirrhosis caused by hepatitis B or hepatitis C infection. Specifically, hepatocytes undergo DNA changes that disrupt their normal growth and life cycle that lead to rapid and uncontrolled cell growth and multiplication, as well as an inability for these cells to die when they should. The overproduction of cells results in the formation of a tumor that can invade and destroy surrounding healthy liver tissue. Eventually, these cancer cells can detach from the primary tumor and spread to other areas of the body, known as metastatic cancer.²

While symptoms may take time to develop, individuals could experience weight loss without trying, loss of appetite, upper abdominal pain, a growth in the abdomen, and yellowing of the skin and whites of the eyes, known as jaundice. Risk factors that could increase the development of HCC, along with chronic liver conditions, include older age, excess fat in the liver, diabetes, obesity, exposure to aflatoxins, excessive alcohol consumption, and cigarette smoking.²

"The expanded indication makes SIR-Spheres^® the only Y-90 treatment approved in the U.S. for both HCC and mCRC," Matt Schmidt, CEO of Sirtex, said in a news release. "This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empower physicians to treat patients when and where it works best."¹

Role of Y-90 Resin Microspheres

Radioembolization, also known as selective internal radiation therapy (SIRT), using Y-90 resin microspheres provides a personalized approach to treating HCC. The company noted that this method delivers a precise and optimal dose of radiation directly to liver tumors based on individual patient needs. This approval offers doctors more flexibility in choosing a liver cancer treatment that best fits their patients’ specific situations and treatment goals.¹

DOORwaY⁹⁰ Study Results

The approval was supported by data from the prospective, multicenter, open-label, single-arm DOORwaY⁹⁰ study that evaluated the safety and efficacy of Y-90 resin microspheres in individuals with unresectable HCC. A total of 100 individuals were enrolled in the study, with 65 individuals included in the primary efficacy cohort. The coprimary end points of the study involved the best overall response rate (ORR) through 9 months along with the duration of response (DoR) through 12 months, using localized mRECIST criteria for both.³

The study achieved both coprimary end points with a best ORR of 98.5% and the best complete response of 92.2%. The DoR has a median of 300.5 days, with 76.6% at greater than 6 months. Additionally, all evaluable patients demonstrated a 100% local tumor control rate.³

All 100 patients also displayed a favorable safety profile with 85% mild to moderate adverse events and 4 device- or procedure-related serious adverse events, including abdominal pain, radioembolization-induced liver disease, and nausea. Approximately 95% of patients had stable liver function.³

"This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” Armeen Mahvash, interventional radiologist at MD Anderson Cancer Center and co-principal investigator of the DOORwaY⁹⁰ study, said in the news release. “This will give multidisciplinary care teams the confidence to recommend [Y-90 resin microspheres] for HCC treatment."¹

REFERENCES

1. Sirtex Medical’s SIR-Spheres^® Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma. SIRTeX. News release. July 7, 2025. Accessed July 7, 2025. https://www.sirtex.com/us/news/press-releases/news-item?id=11510

2. Mayo Clinic. Liver cancer. News release. April 28, 2023. Accessed July 7, 2025. https://www.mayoclinic.org/diseases-conditions/hepatocellular-carcinoma/cdc-20354552

3. DOORwaY⁹⁰ Study Interim Results. SIRTeX. Accessed July 7, 2025. https://www.sirtex.com/us/products/sir-spheres/clinical-trials/doorway90-study/doorway90-study-interim-results/