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Delcath's HEPZATO KIT (melphalan/Hepatic Delivery System) is FDA approved and has demonstrated clinically meaningful tumor shrinkage with reduced systemic toxicity in metastatic uveal melanoma. Ongoing trials target other liver-dominant cancers, including metastatic breast and colorectal cancer. The pivotal FOCUS Phase 3 trial provided the efficacy basis for FDA approval[3][4].
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