Complete response for Delcath's Melblez Kit

FDA issued a complete response letter for an NDA for Melblez Kit chemosaturation system from Delcath Systems Inc. (NASDAQ:DCTH) to treat unresectable ocular melanoma that is metastatic to the liver. According to Delcath, the agency requested an additional trial to establish the safety and efficacy of Melblez Kit and show its benefits outweigh its risk. In May, an FDA panel voted 16-0 that the benefit-risk profile of Melblez Kit did not support approval. Delcath markets the percutaneous intra-arterial hepatic perfusion system that delivers melphalan in Europe. Delcath said it will "review potential regulatory paths forward with FDA" but declined to disclose details.

Delcath also said Eamonn Hobbs was terminated as president and CEO on Tuesday. Hobbs also resigned as a director. Jennifer Simpson, EVP and global head of business operations, and Graham Miao, EVP and CFO, are serving as interim co-president and co-CEO. Gabriel Leung, a director, was appointed chairman, replacing Harold Koplewicz, who remains a director. ...