Key Takeaways
- FDA Approval Expands Use. SIR-Spheres Y-90 is now the first radioembolization therapy approved in the United States for both unresectable hepatocellular carcinoma (HCC) and metastatic colorectal cancer of the liver.
- Strong Clinical Evidence. DOORwaY90 trial results showed a 98.5% overall response rate and 100% local tumor control in patients with Barcelona Clinic liver cancer stage A–C HCC.
- Growing Liver Cancer Burden. Liver cancer incidence has more than tripled since the 1980s, with HCC accounting for nearly 75% of new US cases in 2024.
The FDA has approved Sirtex Medical’s SIR-Spheres Y-90 resin microspheres to treat adults with unresectable hepatocellular carcinoma (HCC). According to the company, this marks the first radioembolization therapy to be cleared in the United States for both HCC and metastatic colorectal cancer (mCRC) of the liver. Approval was based on results from the DOORwaY90 trial (NCT04736121).1,2
What does FDA Approval of SIR-Spheres Y-90 Mean for Liver Cancer Treatment?
"The expanded indication makes SIR-Spheres, the only Y-90 treatment approved in the US for both HCC and mCRC," said Matt Schmidt, CEO, Sirtex, in a press release. "This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empowers physicians to treat patients when and where it works best."1
DOORwaY90 Trial Results Support First-Line Use in HCC
- The prospective, multicenter, open-label, single-arm DOORwaY90 trial evaluated the safety and efficacy of selective internal radiation therapy using SIR-Spheres Y-90 resin microspheres as a first-line treatment for local control in 100 HCC patients with Barcelona Clinic liver cancer stage A, B1, B2, and C.
- The dual primary endpoints of the trial were overall response rate (ORR) and duration of response (DOR).
- Key secondary endpoints included, but were not limited to, the incidence of liver resection, incidence of liver transplant, and grade ≥ 3 toxicity according to Common Terminology Criteria for Adverse Events.2
- Results show that the SIR-Spheres Y-90 resin microspheres cohort achieved a 98.5% ORR and 100% local tumor control, with a median DOR exceeding 300 days.
- The safety profile of the SIR-Spheres Y-90 resin microspheres was reported to be well tolerated.1,2
Liver Cancer Incidence Continues to Rise in the United States
- According to Medscape, liver cancer is the fastest-growing cancer in the United States in both men and women. Since the 1980s, incidence rates have more than tripled.
- In 2024, it was estimated that approximately three out of every four new cases of liver cancer in the United States were HCC. In the United States, the median age of onset is 66 years.
- Notably, liver cancer is more common in men, with an incidence rate of 14.1 per 100,000 compared to 5.2 in women. The risk increases with age, with the highest proportion of cases found in people aged 55 to 64 years at 31.6% and 33.7% in people aged 65 to 74 years.
- Globally, incidence rates among individuals under 30 years of age and those between 30 and 59 years of age have decreased, primarily as a result of widespread hepatitis B vaccination programs.3
Colorectal Cancer Remains a Leading Driver of Liver Metastases
- According to the Mayo Clinic, 15% of all colorectal cancer cases have already spread to the liver by the time they are diagnosed, with 60% of cases eventually spreading to the liver.4
- According to the American Cancer Society, colorectal cancer is the third most diagnosed cancer type in the United States, outside of skin cancers, in both men and women.
- By the end of 2025, it is estimated that there will be approximately 107,320 new cases of colon cancer and 46,950 new cases of rectal cancer in the United States.
- While incidence rates in older adults dropped by 1% between 2012 and 2021 each year, rates in people under 50 years increased by 2.4% in the same period.5
"This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” said Armeen Mahvash, interventional radiologist, MD Anderson Cancer Center, co-principal Investigator of the DOORwaY90 trial, in the press release. “This will give multidisciplinary care teams the confidence to recommend SIR-Spheres 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. July 7, 2025. Accessed July 8, 2025. https://www.sirtex.com/us/news/press-releases/news-item?id=11510
2. Selective Internal Radiation Therapy (SIRT) Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients (DOORwaY90). Clinicaltrials.gov. Accessed July 8, 2025. https://clinicaltrials.gov/study/NCT04736121?term=NCT04736121&rank=1
3. Hepatocellular Carcinoma (HCC). Medscape. October 14, 2024. Accessed July 8, 2025. https://emedicine.medscape.com/article/197319-overview#a6
4. Colorectal cancer in the liver: New treatment gives more people hope for a cure. Mayo Clinic. May 4, 2023. Accessed July 8, 2025. https://cancerblog.mayoclinic.org/2023/05/04/colorectal-cancer-in-the-liver-new-treatment-gives-more-people-hope-for-a-cure/
5. Key Statistics for Colorectal Cancer. American Cancer Society. Accessed July 8, 2025. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
