The Food and Drug Administration announced yesterday the approval of HEPZATO Kit to treat ocular melanoma that has spread to the liver. HEPZATO uses a hepatic delivery system to inject the chemotherapy drug melphalan into the liver, a procedure referred to as percutaneous hepatic perfusion (PHP).
Moffitt Cancer Center’s Jonathan S. Zager, M.D., was the lead international principal investigator on the multinational FOCUS phase 3 clinical trial to test the procedure, which is manufactured by Delcath Systems, Inc.
Unlike traditional chemotherapy that circulates throughout the entire body, percutaneous hepatic perfusion uses a series of catheters and balloons to isolate the liver from the body’s circulatory system, allowing for high dose chemotherapy to be delivered directly to the liver only.
The blood is collected as it exits the liver and filtered outside the body via a bypass circuit to remove any remaining chemo. Patients can receive percutaneous hepatic perfusion up to six times, usually performed six to eight weeks apart.
Uveal melanoma is a cancer that originates in the eye. Roughly 4,500 people receive the diagnosis each year. About half of those patients will develop metastatic disease, with 90% of those metastases being solely or predominately in the liver.
Moffitt led the pivotal international trial, which began in 2016 and included 40 institutions in the U.S. and Europe. The trial accrued 102 patients to the percutaneous hepatic perfusion arm. In June 2022, Zager shared final phase 3 results at the American Society of Clinical Oncology Annual Meeting.
Moffitt enrolled and treated the first and last patients on the FOCUS phase 3 trial and has performed the procedure nearly 200 times to date.
