On January 19, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the Company has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of Delcath’s new Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (Press release, Delcath Systems, JAN 19, 2016, View Source [SID:1234508808]). Schedule your 30 min Free 1stOncology Demo! The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS.
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The agreement also represents the satisfactory resolution of a substantial number of the FDA’s issues in the Complete Response Letter (CRL) issued in September 2013. These issues were related to safety of a previous generation of the Melphalan/HDS device and procedure. Delcath completed the work necessary to satisfy these requirements prior to submitting its request for the SPA agreement.
The new pivotal trial, the FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS trial), will evaluate the safety and efficacy profile of the Melphalan/HDS versus best alternative care. The primary endpoint will be overall survival, and secondary endpoints will include progression-free survival, overall response rate and quality-of-life measures. Full details of the Phase 3 clinical trial will be made public upon the launch of the study and will be available at www.clinicaltrials.gov.
"This agreement marks a major milestone for Delcath," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "Under this SPA our new FOCUS trial, if successful, will provide a clear pathway to an indication in hepatic dominant ocular melanoma for Melphalan/HDS. Additionally, through the dedicated work of our team and in close collaboration with the FDA, we have satisfied a substantial number of the requirements of the FDA’s 2013 CRL. 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. There is strong interest from leading cancer centers in the U.S. and Europe to participate in this study and we look forward to beginning enrollment in this registrational trial."
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application. Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.