FDA Approves SIR-Sphere Y-90 in HCC
SIR-Sphere Y-90 resin microspheres are the only approved radioembolization treatments in the US for both HCC and mCRC.
SIR-Sphere Y-90 resin microspheres are the only approved radioembolization treatments in the US for both HCC and mCRC.
The FDA has approved SIR-Spheres Y-90 resin microspheres as treatment for patients with hepatocellular carcinoma (HCC), according to a press release from Sirtex Medical.1
Results from the DOORwaY90 study (NCT04736121) led to the approval. The safety and efficacy of selective internal radiation therapy using the SIR-Spheres Y-90 resin microspheres was evaluated in the study.2
"The expanded indication makes SIR-Spheres the only Y-90 treatment approved in the US for both HCC and [metastatic colorectal cancer]," said Matt Schmidt, CEO of Sirtex. "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."
The trial enrolled 100 patients in 18 US states, with 65 patients completing the interim primary efficacy cohort. Of note, the overall response rate was 98.5% assessed by independent central review. Additionally, there was a 100% local tumor control rate, and the median duration of response exceeded 300 days.
References
- Sirtex Medical’s SIR-Spheres® Y-90 resin microspheres receive FDA approval for the treatment of unresectable hepatocellular carcinoma. News release. Sirtex. July 7, 2025. Accessed July 7, 2025. https://tinyurl.com/w84rauhj
- Mahvash A, Chartier S, Turco M, et al. A prospective, multicenter, open-label, single-arm clinical trial design to evaluate the safety and efficacy of 90Y resin microspheres for the treatment of unresectable HCC: the DOORwaY90 (Duration Of Objective Response with arterial Ytrrium-90) study. BMC Gastroenterol. 2022;22(1):151. doi:10.1186/s12876-022-02204-1
