The Hepzato Kit has been approved in Europe since 2012 and is marketed as Chemosat hepatic delivery system for liver cancers. Image Credit: JHVEPhoto / Shutterstock.

Delcath Systems’ Hepzato Kit (melphalan/hepatic delivery system) has been approved by the US Food and Drug Administration (FDA) for treating metastatic uveal melanoma.

Uveal melanoma is an ophthalmic cancer with a high chance of metastasis. The Hepzato Kit specifically focuses on treating the extra-ocular metastases of uveal melanoma, which affect either up to 50% of the liver tissue without extrahepatic disease, or metastases limited to extrahepatic organs namely bone, lymph nodes, subcutaneous tissue, or lung.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The approval comes as welcome news for the company as it unlocks additional funding of $34.9m, from its Private Investment in Public Equity (PIPE) financing tranch. Additionally, Delcath’s stock shot to more than 80% in pre-market trading on 15 August following the approval announcement, compared to the market close on the previous day.

Delcath plans to launch the Hepzato Kit in Q4 2023, with the company’s CEO stating: “We look forward to partnering with cancer centres across the country to build a network of treatment sites trained in the use of this novel therapy.”

The Hepzato Kit has been approved in Europe since 2012 and is marketed as Chemosat hepatic delivery system for liver cancers. It uses percutaneous infusion to administer melphalan hydrochloride through Delcath’s proprietary filters for more than 30 minutes followed by a 30-minute washout.

See Also:

The US approval was based on an open-label Phase III study (NCT02678572). The trial administered the Hepzato Kit for up to six treatments, with a gap of six to eight weeks in between treatments, to both treatment-naïve and previously treated adults with hepatic and extrahepatic lesions. The objective response rate for the treatment was 36.3%, with the response lasting for 14 months (median duration of response).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Approximately 73.6% of the 91 patients enrolled in the trial reported clinical benefit, with 7.7% and 28.6% of the patients reporting complete and partial responses, respectively. The most common side effect of the therapy is a decrease in blood cell counts.

Delcath plans to expand indications for the Hepzato Kit to include cholangiocarcinoma and other primary and metastatic liver cancers.