Delcath’s Hepzato Kit Launched for Treatment of Metastatic Uveal Melanoma

January 16, 2024—Delcath Systems, Inc. announced the first commercial use of Hepzato Kit for the treatment of metastatic uveal melanoma (mUM). The procedures were conducted by Jonathan S. Zager, MD, at Moffitt Cancer Center in Tampa, Florida.

In August 2023, the company announced FDA approval of the combination drug/device product, which administers Hepzato (melphalan) directly to the liver through the hepatic delivery system, permitting higher drug exposure in target tissues while limiting systemic toxicity.

According to the company, the approval was based primarily on the results of the FOCUS phase 3 trial.

Dr. Zager, global Lead Investigator for FOCUS, enrolled and treated the first and last patients in the trial. The team at Moffitt has performed the procedure > 200 times to date.

“The fact that patients with difficult-to-treat mUM with limited treatment options now have another alternative is truly remarkable and exciting,” commented Dr. Zager in Delcath Systems’ press release. “There has been a large unmet need for liver-directed therapy options to treat this patient population, and we intend to incorporate this as standard of care for appropriate patients.” Dr. Zager is Chief Academic Officer; Senior Member, Department of Cutaneous, Oncology; and Director of Regional Therapies at Moffitt Cancer Center.

Hepzato Kit is FDA approved in the United States as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting < 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.