DELCATH SYSTEMS RECEIVES SPA AGREEMENT FROM FDA
The FDA has given special protocol assessment agreement (SPA) for Delcath Systems' new liver cancer treatment, the company announced.
The company completed an SPA for the treatment of metastatic melanoma in the liver using the Delcath system with melphalan, an approved anticancer agent. Under the terms of the SPA, the company is required to complete one Phase III trial in order to file a premarket approval application.
The randomized, multicenter trial will enroll 92 patients diagnosed with ocular and cutaneous melanoma metastatic cancer in the liver. Patients will be randomized to either the Delcath system using melphalan or a control group receiving the best alternative care. Patients in the control group will be reviewed on a case-by-case basis and receive an existing treatment option deemed appropriate by the principal investigator.