January 3, 2017 — Sirtex Medical Limited announced in December that SIR-Spheres Y-90 resin microspheres have been included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. This designation denotes there is uniform consensus among the NCCN panel that selective internal radiation therapy (SIRT) with yttrium-90 microspheres is an appropriate option in patients with liver dominant, chemotherapy resistant colorectal disease (mCRC). This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens.
The new NCCN Guidelines are available online at https://www.nccn.org/professionals/physician_gls/f_guidelines.asp
According to Sirtex Americas CEO Kevin Richardson, the company has positive signals in the first-line setting from the results to-date of the SIRFLOX study1 and expects results from the SIRFLOX, FOXFIRE and FOXFIRE Global studies in the first half of 2017.
These findings are also supported by the landmark MORE study2, a large retrospective analysis conducted in the United States with SIR-Spheres Y-90 resin microspheres in more than 600 mCRC patients. The MORE study helped to increase the understanding of SIRT as a treatment option for patients who have failed multiple lines of chemotherapy, while highlighting the positive aspects of the safety and efficacy of the protocol for patients of all ages.
“Clinical research has shown that SIRT brings patients with colorectal liver metastases improved and prolonged quality of life,” said lead investigator of the MORE study, Andrew S. Kennedy, M.D., FACRO, director, radiation oncology research at Sarah Cannon Research Institute, Nashville, Tenn. “We look forward to expanding access to this outpatient procedure, which has demonstrated minimal side effects, to improve outcomes for this population of patients and advance the standard of care.”
SIR-Spheres Y-90 resin microspheres are the first and only microspheres with U.S. Food and Drug Administration (FDA) premarket approval (PMA) for colorectal cancer that has metastasized to the liver.3
For more information, visit www.sirtex.com.
1. van Hazel GA, Heinemann V, Sharma NK et al. SIRFLOX: Randomized Phase III trial comparing first-line mFOLFOX6 (plus or minus bevacizumab) plus selective internal radiation therapy in patients with metastatic colorectal cancer. Journal of Clinical Oncology. 2016; 34: 1723–1731.
2. Kennedy AS, Ball D, Cohen SJ et al. Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres. Journal of Gastrointestinal Oncology. 2015; 6: 134–142
3. SIR-Spheres microspheres (Yttrium-90 Microspheres) Product Information. Available at: www.sirtex.com/us/clinicians/package-insert/. Assessed on December 8, 2016.