Sirtex has announced 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 that 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. This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens. SIRT can also be carried out using glass microspheres. BTG’s TheraSphere is currently FDA-cleared only for hepatocellular carcinoma treatment in the USA, but approved for liver neoplasia in other geographies.
The new NCCN Guidelines are available online at https://www.nccn.org/professionals/physician_gls/f_guidelines.asp
Nearly 140,000 Americans are diagnosed with colorectal cancer every year, more than 50% of whom will see the cancer spread to their liver. “The NCCN Guidelines aim to assist medical teams, patients and their families in making informed treatment-related decisions with the goal of optimal cancer care,” said Kevin Richardson, chief executive officer for Sirtex Americas.
“The 2A designation represents a very important milestone for SIR-Spheres resin microspheres and provides further validation for the role of our medical device as an important treatment option for unresectable, liver dominant metastatic colorectal cancer. We also have positive signals in the first-line setting through the results to date of the pivotal SIRFLOX study and eagerly anticipate the overall survival results in more than 1,100 patients from the SIRFLOX, FOXFIRE and FOXFIRE Global studies which we expect to be available in the first half of 2017.” These findings are also supported by the landmark MORE study, a large retrospective analysis conducted in the USA 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, director, Radiation Oncology Research, Sarah Cannon Research Institute, Nashville, USA. “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 FDA premarket approval for colorectal cancer that has metastasised to the liver, a press release from Sirtex adds.