FDA approves expanded use of radioembolization therapy for liver cancer

The U.S. Food and Drug Administration has just approved a radioembolization agent for the treatment of unresectable hepatocellular carcinoma (HCC). 

Sirtex Medical—a manufacturer of oncology solutions—announced the approval of its SIR-Spheres, which are Y-90 resin microspheres injected directly into tumors, earlier this week, praising the FDA’s move to expand the radioembolization therapy’s indications to HCC. The microspheres were already approved for the treatment of metastatic colorectal cancer of the liver. The expanded approval makes SIR-Spheres the first Y-90 treatment available for use in both conditions. 

"The expanded indication makes SIR-Spheres the only Y-90 treatment approved in the U.S. for both HCC and [metastatic colorectal cancer]," Matt Schmidt, CEO of Sirtex, said in the announcement. "This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empower physicians to treat patients when and where it works best." 

The approval follows promising results from the DOORwaY90 study, which tested the spheres in patients with HCC. The prospective, multicenter trial showed that treatment yielded an overall responses rate of 98.5% in HCC patients, with a 100% local tumor control rate. What’s more, the median duration response exceeded 300 days and researchers determined the treatment has a positive safety profile. 

Armeen Mahvash, MD, co-principal investigator of the study and an interventional radiologist at MD Anderson Cancer Center, expressed optimism for how the expanded indications can improve the treatment of HCC. 

“This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results,” Mahvash said “This will give multidisciplinary care teams the confidence to recommend SIR-Spheres for HCC treatment." 

Learn more about the approval here.