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Delcath Systems Inc. (Nasdaq: DCTH) is a prominent interventional oncology company focusing on the treatment of primary and metastatic liver cancers. The company's flagship product, the HEPZATO KIT™ (comprising Hepzato (melphalan) for Injection and the Hepatic Delivery System), offers a revolutionary approach to liver-directed chemotherapy. This system enables high-dose chemotherapy delivery directly to the liver, minimizing systemic exposure and associated side effects.
HEPZATO KIT is FDA-approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) presenting unresectable hepatic metastases, especially when the metastases affect less than 50% of the liver and there is no extrahepatic disease, or extrahepatic disease limited to specific regions like bone or lymph nodes that can be managed surgically or through radiation. The product's approval followed the pivotal Phase 3 FOCUS study, which demonstrated a significant improvement in overall response rates and progression-free survival compared to historical data.
In Europe and the United Kingdom, Delcath markets the product under the trade name CHEMOSAT® Hepatic Delivery System for Melphalan. This device-only configuration has been utilized in over 250 treatments across 20 leading European cancer centers, establishing itself as a reliable option for liver cancer therapy.
Delcath continues to make strides in enhancing treatment accessibility. Recently, the company launched a Healthcare Setting Locator on their website to help patients, caregivers, and healthcare providers find facilities offering HEPZATO KIT treatment. The company also secured a permanent J-code for HEPZATO, streamlining the reimbursement process and facilitating broader patient access.
Recent business highlights include the first commercial use of HEPZATO KIT at Moffitt Cancer Center and the successful closing of a $7 million private placement to support ongoing commercial endeavors. Delcath has also published significant data from the FOCUS study in the Annals of Surgical Oncology, reinforcing the clinical efficacy of their treatment.
As Delcath Systems Inc. forges ahead, they remain committed to expanding the clinical adoption of their innovative therapies in major markets, thus providing critical treatment options to liver cancer patients worldwide.
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