FDA Approves SIR-Spheres for Liver Cancer Treatment

The U.S. Food and Drug Administration (FDA) approved SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the U.S., marking the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S, according to a news release from Sirtex Medical.

“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, stated in the news 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.”

HCC is the most common type of liver cancer in adults in the U.S., according to the American Cancer Society. One treatment option, radioembolization — also called selective internal radiation therapy (SIRT) — involves delivering targeted radiation directly to liver tumors, in this case using SIR-Spheres. This approach uses personalized dosimetry to help ensure each patient receives an appropriate dose. The new approval expands clinicians’ ability to choose a liver-directed therapy that matches each patient’s unique needs and goals, as per the release.

This regulatory milestone is based on findings from the DOORwaY90 study, a prospective, multicenter, open-label trial that evaluated the safety and effectiveness of SIR-Spheres for treating hepatocellular carcinoma. The study enrolled 100 patients across 18 U.S. sites, with 65 included in the interim primary efficacy analysis.

The trial met its prespecified co-primary endpoints, with an overall response rate of 98.5% as assessed by independent central review. All evaluable patients responded to treatment, resulting in a 100% local tumor control rate. The median duration of response exceeded 300 days. These results support SIR-Spheres as a highly effective liver-directed therapy with a favorable safety profile, according to the release.

“This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” Dr. 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 SIR-Spheres for HCC treatment.”

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