Delcath resubmits NDA to FDA for HEPZATO Kit in metastatic ocular melanoma

DELCATH SYSTEMS, INC.

NDA resubmission for HEPZATO Kit (melphalan/HDS) to FDA for unresectable hepatic-dominant metastatic ocular melanoma.
FDA to determine if resubmission is complete response to Sept 2013 CRL within 30 days; if accepted, PDUFA date set.
FOCUS trial results: ORR 36.3%, CR 7.7%, median DOR 14 months, DCR 73.6%, updated median OS 20.53 months.
Safety: 41.1% treatment-related serious AEs; no treatment-related deaths.

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