The U.S. Food and Drug Administration (FDA) has cleared radiation oncology firm Sirtex Medical's SIR-Spheres Y-90 (yttrium-90) resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC).
With the clearance, SIR-Spheres is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer of the liver and HCC in the U.S., according to the firm.
Radioembolization uses dosimetry to deliver radiation directly to tumors in patients with HCC, according to Sirtex. This FDA approval gives clinicians "expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals," it noted in a statement.
The company's FDA 510(k) application was supported by results from a study called DOORwaY90 that evaluated the safety and efficacy of SIR-Spheres for treating HCC. The study included 100 patients from 18 U.S. centers, and met its co-primary endpoints, showing a best overall response rate of 98.5%, Sirtex said.
