GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Melphalan hydrochloride overview
Melphalan hydrochloride (Hepzato, Hepzato Kit) is a phenylpropanoic acid derivative of the alkylating drug and acts as an antineoplastic agent. It is formulated as a lyophilized powder for a solution for the intraarterial route of administration. Hepzato is indicated as a liver-directed treatment for adult patients with uveal melanoma 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.
Melphalan hydrochloride in combination with chemosaturation therapy is under development for the treatment of colorectal cancer, intrahepatic cholangiocarcinoma (bile duct cancer (cholangiocarcinoma), ocular melanoma metastatic to the liver and liver metastasis of uveal melanoma. The drug is administered by intrahepatic arterial infusion. The drug candidate was also under development for hepatocellular carcinoma, unresectable sarcoma of the extremity, adenocarcinomas of gastrointestinal origin, neuroendocrine tumors, cutaneous melanoma metastatic to the liver.
Delcath Systems overview
Delcath Systems (Delcath) specializes in developing percutaneous hepatic perfusion technologies to treat primary and metastatic liver cancers. Its patented drug delivery platform delivers ultra-high doses of chemotherapeutic agents to the liver while preventing them from entering the patient’s bloodstream. The company’s lead product is Melphalan Hydrochloride for Injection for use with the proprietary Delcath Hepatic Delivery System (HEPZATO KIT) to administer high-dose chemotherapy to the liver. The company sells its proprietary system to deliver and filter melphalan hydrochloride in Europe under the trade name Delcath Chemosat Hepatic Delivery System for Melphalan (Chemosat). Delcath is headquartered in New York, the US.
For a complete picture of Melphalan hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.