Sirtex’s SIR-Spheres Approved to Treat Unresectable HCC

July 7, 2025—Sirtex Medical announced that the FDA has approved the company’s SIR-Spheres yttrium-90 (Y90) resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States. Radioembolization—also known as selective internal radiation—therapy with SIR-Spheres is now approved in the United States for the treatment of both metastatic colorectal cancer of the liver and HCC, noted the company.

According to Sirtex, FDA approval is supported by results from the DOORwaY⁹⁰ study evaluating the safety and efficacy of SIR-Spheres Y90 device in treating HCC. The prospective, multicenter, open-label clinical trial enrolled 100 patients at 18 centers in the United States, with 65 patients included in the interim primary efficacy cohort.

Sirtex advised that the DOORwaY⁹⁰ findings demonstrated that treatment with SIR-Spheres is a highly effective liver-directed therapy with a favorable safety profile.

As summarized in the company’s press release, the trial met its prespecified coprimary endpoints with an overall response rate of 98.5% as assessed by an independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response exceeded 300 days.

Armeen Mahvash, MD, an interventional radiologist at MD Anderson Cancer Center in Houston, Texas, serves as Coprincipal Investigator of the DOORwaY⁹⁰ study.

“This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” commented Dr. Mahvash in Sirtex’s press release. “This will give multidisciplinary care teams the confidence to recommend SIR-Spheres for HCC treatment.”