After enduring nearly a decade of setbacks, Delcath has finally achieved a regulatory milestone in the United States. Delaware-based Delcath proudly announced that its Hepzato Kit has secured FDA approval as a liver-directed treatment for select adult patients battling metastatic uveal melanoma (mUM) with unresectable hepatic metastases.
Uveal melanoma, a rare form of cancer affecting the eye, becomes even more challenging when it metastasizes. Over 90% of mUM cases involve the liver, frequently leading to liver failure and tragic outcomes for patients.
Delcath’s innovative Hepzato Kit encompasses a drug/device combination that introduces the well-established chemotherapy agent melphalan directly into the liver through a procedure known as percutaneous hepatic perfusion.
“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.”
– Gerard Michel, Delcath’s Chief Executive Officer
This “minimally invasive” technique employs percutaneous catheters to momentarily isolate the liver from the body’s circulatory system. In a mere half-hour timeframe, the device administers melphalan hydrochloride directly to the liver. Proprietary filters integrated into the device facilitate the blood filtering process, channeling treated blood back into the circulatory system.
Chemosat, the product’s counterpart, earned a CE mark in Europe back in 2012, making it accessible across the continent. In 2013, however, Delcath faced an FDA rejection, being instructed to conduct additional controlled trials to establish the medication’s risk-benefit ratio.
“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.”
– Vojislav Vukovic, Delcath’s Chief Medical Officer
Notably, the treatment procedure employed by the Hepzato Kit is already endorsed by the National Comprehensive Cancer Network (NCCN) treatment guidelines.
Delcath is gearing up for a commercial launch of Hepzato Kit in the fourth quarter of 2023. Meanwhile, the company remains committed to offering the treatment via its expanded access program.
Delcath’s triumphant achievement resonated positively with investors, leading to an almost doubling of its stock price. As of Tuesday morning, the stock was trading around $6.00, signifying newfound investor confidence in the company’s prospects.
