This article is more than 5 years old. Information may no longer be current.
Delcath, FDA reach agreement over melphalan for hepatic melanoma
Click Here to Manage Email Alerts
Delcath Systems, Inc. announced it has reached a special protocol assessment agreement with the FDA for the design of its new phase 3 FOCUS trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System for the treatment of hepatic dominant ocular melanoma.
Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) — which is considered a combination drug and device product in the U.S. — is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure. Under the agreement, the FOCUS trial must address certain objectives that would help support the submission for regulatory approval of Melphalan/HDS, according to a press release.
In addition, the agreement includes the resolution of a number of safety issues the FDA had and stated in a Complete Response Letter to Delcath in September 2013. The release said that Delcath “completed the work necessary to satisfy these requirements prior to submitting its request for the [special protocol assessment] agreement.”
“Under this [special protocol assessment], our new FOCUS trial, if successful, will provide a clear pathway to an indication in hepatic dominant ocular melanoma for Melphalan/HDS,” Jennifer K. Simpson, PhD, MSN, CRNP, president and CEO of Delcath, said in the release. “Based on our commercial experience in Europe, the continued support and enthusiasm from key opinion leaders and the clinical data that have been presented and published recently, we have confidence that our FOCUS trial can demonstrate the efficacy and safety necessary for a positive benefit/risk profile for Melphalan/HDS, and that the study’s objectives can be met.”
The primary endpoint of FOCUS will be overall survival, and secondary endpoints include progression-free survival, overall response rate and quality-of-life measures.
The FDA granted orphan drug designation to melphalan for the treatment of patients with cholangiocarcinoma in July 2015.
Disclosure: Simpson is employed by Delcath Systems.