DELCATH RECEIVES SPA AND AGREEMENT FROM FDA FOR CANCER STUDY

Delcath Systems has successfully completed a special protocol assessment and agreement (SPA) with the FDA 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 to the liver. Patients who are selected to participate in the trial will be randomized to either the Delcath system using melphalan or a control group receiving best alternative care. Patients in the control group will be reviewed on a case-by-case basis and receive an existing treatment option deemed most appropriate by the principal investigator.

The primary endpoint is to determine whether patients using the Delcath system will experience a reduction in tumor burden or zero progression of the metastatic melanoma in their liver longer than those receiving best alternative care. Participants randomized to the control group whose tumors are found to progress will be allowed to cross over and receive treatment using the Delcath system.