Sirtex Medical Limited announced that SIR-Spheres Y-90 resin microspheres has 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 (mCRC). This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens.

Nearly 140,000 Americans are diagnosed with colorectal cancer every year1, more than 50 percent of whom will see the cancer spread to their liver.2 “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 study3 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 study4, 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., F.A.C.R.O., 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 FDA premarket approval (PMA) for colorectal cancer that has metastasized to the liver.

SIR-Spheres Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolization, which targets high doses of radiation directly to liver tumours. The treatment consists of tens of millions of radioactive Y-90 coated resin particles, each no bigger in diameter than a human hair. Interventional radiologists inject these resin particles, or microspheres, into the hepatic artery via a catheter inserted into the femoral artery through an incision in the groin. The Y-90 resin microspheres become lodged in the capillaries that surround liver tumours, where they deliver a high dose of short-range (mean 2.5 mm; maximum 11 mm) beta radiation to the liver tumours, while sparing healthy liver tissue. The low specific gravity of the Y-90 resin microspheres allows the blood flow to distribute the radioactivity within and around the liver tumours.

SIR-Spheres Y-90 resin microspheres have a Premarket Approval (PMA) by the FDA and are indicated for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumours in Australia, the European Union, Argentina, Brazil, Canada and several countries in Asia, such as India and Singapore.

The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives.

Sirtex Medical Limited is an Australian-based global healthcare business working to improve outcomes in people with cancer.