{"id":813390,"date":"2025-02-14T08:33:12","date_gmt":"2025-02-14T13:33:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/delcath-systems-announces-update-to-national-comprehensive-cancer-network-clinical-practice-guidelines-for-the-treatment-of-metastatic-uveal-melanoma\/"},"modified":"2025-02-14T08:33:12","modified_gmt":"2025-02-14T13:33:12","slug":"delcath-systems-announces-update-to-national-comprehensive-cancer-network-clinical-practice-guidelines-for-the-treatment-of-metastatic-uveal-melanoma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/delcath-systems-announces-update-to-national-comprehensive-cancer-network-clinical-practice-guidelines-for-the-treatment-of-metastatic-uveal-melanoma\/","title":{"rendered":"Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma"},"content":{"rendered":"

<\/p>\n

Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma<\/b><\/p>\n

QUEENSBURY, N.Y.–(BUSINESS WIRE<\/a>)–
\nDelcath Systems, Inc. (Nasdaq: DCTH) (\u201cDelcath\u201d or the \u201cCompany\u201d), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae<\/sup>) for the treatment of metastatic uveal melanoma (mUM). Our proprietary products, HEPZATO KIT\u2122 (HEPZATO (melphalan) for Injection\/Hepatic Delivery System) and CHEMOSAT\u00ae<\/sup> Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver.<\/p>\n

\nThe updated NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma. Previously, the guidelines limited its use to patients with metastases confined to the liver. This revision aligns with the HEPZATO KIT label. Given that over 90% of mUM patients develop liver metastases, and the liver is typically the life-limiting organ, this update expands the recommended patient population for which HEPZATO KIT may be considered an appropriate treatment option. A previously published subgroup analysis from the Phase 3 FOCUS trial demonstrated no significant differences in objective response rate, progression-free survival, or overall survival between patients with and without extrahepatic disease.<\/p>\n

\n\u201cWe are encouraged by the NCCN\u2019s decision to expand HEPZATO\u2019s recommendation in the guidelines to include patients with extrahepatic disease, recognizing the critical role hepatic progression plays in the course of metastatic uveal melanoma,\u201d said Gerard Michel, Chief Executive Officer of Delcath. \u201cThis update underscores the growing recognition of HEPZATO as an important treatment option for patients battling this challenging disease.\u201d<\/p>\n

About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT<\/b><\/p>\n

\nDelcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT\u2122 (HEPZATO (melphalan) for Injection\/Hepatic Delivery System) and CHEMOSAT\u00ae<\/sup> Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.<\/p>\n

\nIn the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for 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. Please see the full Prescribing Information<\/a>, including BOXED WARNING for the HEPZATO KIT.<\/p>\n

\nIn Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.<\/p>\n

Safe Harbor \/ Forward-Looking Statements<\/b><\/p>\n

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company’s successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers\/manufacturers; the Company’s successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company’s ability to obtain reimbursement for the HEPZATO KIT; and the Company’s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the Company, please see the Company’s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.<\/i><\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250214098555\/en\/<\/a><\/span><\/p>\n

Investor Relations:
\n<\/b>
ICR Healthcare
\n
investorrelations@delcath.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America New York<\/p>\n

INDUSTRY KEYWORDS:<\/b> Oncology Health Other Health Other Science Research Science Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n","protected":false},"excerpt":{"rendered":"

Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma QUEENSBURY, N.Y.–(BUSINESS WIRE)– Delcath Systems, Inc. (Nasdaq: DCTH) (\u201cDelcath\u201d or the \u201cCompany\u201d), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) for the treatment of metastatic uveal melanoma (mUM). Our proprietary products, HEPZATO KIT\u2122 (HEPZATO (melphalan) for Injection\/Hepatic Delivery System) and CHEMOSAT\u00ae Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver. The updated NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients … <\/p>\n

Continue reading “Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-813390","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nDelcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/delcath-systems-announces-update-to-national-comprehensive-cancer-network-clinical-practice-guidelines-for-the-treatment-of-metastatic-uveal-melanoma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Delcath Systems Announces Update to National Comprehensive Cancer Network Clinical Practice Guidelines for the Treatment of Metastatic Uveal Melanoma QUEENSBURY, N.Y.–(BUSINESS WIRE)– Delcath Systems, Inc. (Nasdaq: DCTH) (\u201cDelcath\u201d or the \u201cCompany\u201d), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) for the treatment of metastatic uveal melanoma (mUM). Our proprietary products, HEPZATO KIT\u2122 (HEPZATO (melphalan) for Injection\/Hepatic Delivery System) and CHEMOSAT\u00ae Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver. 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(Nasdaq: DCTH) (\u201cDelcath\u201d or the \u201cCompany\u201d), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) for the treatment of metastatic uveal melanoma (mUM). Our proprietary products, HEPZATO KIT\u2122 (HEPZATO (melphalan) for Injection\/Hepatic Delivery System) and CHEMOSAT\u00ae Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver. 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