The Delcath Systems Inc (NASDAQ: DCTH) stock price soared 62.5% as of 7:30 EST after the US Food And Drug Administration (FDA) approved the HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases.
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Investors cheered the announcement, which paved the way for Delcath Systems to start marketing the kit within the United States following the FDA approval. The Company intends to have the commercial product ready in Q4 2023, while patients will continue to be enrolled and treated at Expanded Access Program (EAP) sites.
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The HEPZATO KIT will be used to treat adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 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.
The HEPZATO KIT’s approval was based mainly on the results of the FOCUS Study (NCT02678572), a Phase 3, single-arm, multicenter, open-label study, which administered HEPZATO (melphalan) via the hepatic delivery system (HDS) during a PHP procedure.
Ninety-one (91) patients received treatment every 6 to 8 weeks for up to 6 treatments. The patient population enrolled in the FOCUS Study included patients with hepatic and extra-hepatic lesions subject to a treatment plan, as well as both treatment naïve (56.0%) and previously treated (44.0%) patients, irrespective of HLA genotype.
Gerard Michel, Delcath’s CEO, said: “FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company’s commitment to bring this treatment option to patients suffering from metastatic uveal melanoma. We look forward to partnering with cancer centers across the country to build a network of treatment sites trained in the use of this novel therapy.”
Vojislav Vukovic, Delcath’s Chief Medical Officer, said: “HEPZATO KIT is the only liver-directed therapy that can treat the whole liver. Scientific literature supports that HEPZATO KIT may have broad applicability in other tumor types, and we intend to expand our development efforts beyond uveal melanoma given the high incidence of unresectable hepatic dominant tumors.”
Delcath Systems (DCTH) stock price.
The Delcath Systems (DCTH) stock price soared 62.5% to trade at $5.07, rising from Monday’s closing price of $3.12.
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