> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Sirtex Medical Wins Device OK for Liver Cancer
- URL: https://www.fdaweb.com/sirtex-medical-wins-device-ok-for-liver-cancer/
- Published: 2025-07-07T12:00:00.000Z
- Updated: 2026-09-14T15:15:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159459

FDA has approved a Sirtex Medical PMA for its SIR-Spheres Y-90 resin microspheres for treating unresectable hepatocellular carcinoma (HCC) in the United States. HCC is the most common form of liver cancer in adults in the U.S., according to the [American Cancer Society](https://www.cancer.org/cancer/types/liver-cancer/about/what-is-liver-cancer.html?ref=fdaweb.com).

Radioembolization with SIR-Spheres uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC, the company says. “The expanded indication makes SIR-Spheres the only Y-90 treatment approved in the U.S. for both HCC and mCRC \[metastatic colorectal cancer\],” it says.

Approval is based on data from the DOORwaY study that enrolled 100 patients across 18 U.S. centers. The study met its prespecified co-primary endpoints, demonstrating a best overall response rate (ORR) of 98.5% as assessed by independent central review, Sirtex says. “All evaluable patients demonstrated a response, indicating a 100% local tumor control rate,” it adds. “Additionally, the median duration of response (DoR) exceeded 300 days.”