By Fineline Cube 
China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced that SIR-Spheres Y-90 resin microspheres (SIR-Spheres), a radiopharmaceutical developed by its associate company Sirtex Medical Pty Ltd, has received accelerated FDA approval for a new indication in the treatment of unresectable hepatocellular carcinoma (HCC). This approval makes SIR-Spheres the first and only radioembolization therapy approved in the US for both colorectal liver metastases (CRLM) and unresectable HCC.
Clinical Trial Results
The FDA’s decision was supported by interim data from the DOORwaY90 multicenter clinical trial. The trial demonstrated an objective response rate (ORR) of 98.5%, with all evaluable patients showing a treatment response. The local tumor control rate reached 100%, and the median duration of response exceeded 300 days.
Mechanism of Action
SIR-Spheres works by delivering high-energy beta radiation through intra-arterial injection of resin microspheres. This approach combines the advantages of radiopharmaceuticals and precision interventional therapy.
Market Presence
Originally approved in the US and Europe in 2002 for unresectable CRLM, SIR-Spheres received clearance in China in 2022. By 2024, it had been used to treat nearly 2,000 patients in China, generating annual sales of nearly HKD 500 million (USD 64 million).-Fineline Info & Tech