Delcath Systems, Inc. has received approval from the US Food and Drug Administration (FDA) for HEPZATO KIT (melphalan/Hepatic Delivery System). This approval allows for the use of HEPZATO KIT as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting under 50% of the liver without extrahepatic disease, or existing extrahepatic disease must be confined to the bone, lymph nodes, subcutaneous tissues, or lung and be treatable through resection or radiation.
HEPZATO KIT is the sole liver-directed therapy that has received FDA approval for treating mUM and percutaneous hepatic perfusion (PHP).
This approval was primarily based on the outcomes of the Phase 3 FOCUS Study (NCT02678572). This study employed HEPZATO (melphalan) through the hepatic delivery system (HDS) in conjunction with a PHP procedure. The study’s primary objectives were the objective response rate (ORR) and the duration of response (DoR). The study revealed an ORR: 36.3% (CI: 26.4-47.0) with a 14-month median DoR. DCR: 73.6% (CI: 63.3-82.3), including 7 complete and 26 partial responses.
Gerard Michel, the Chief Executive Officer of Delcath, stated that the FDA’s approval of HEPZATO KIT signifies a fresh start for the company and represents the realization of its commitment to providing this treatment choice to individuals suffering from metastatic uveal melanoma. He expressed anticipation of establishing collaborations with cancer centers nationwide to create a network of treatment facilities proficient in applying this innovative therapy.
Source: Delcath Systems, Inc. announces FDA Approval of HEPZATO KIT™ for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma.
https://www.prnewswire.com/news-releases/delcath-systems-inc-announces-fda-approval-of-hepzato-kit-for-the-treatment-of-adult-patients-with-unresectable-hepatic-dominant-metastatic-uveal-melanoma-301900346.html
