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FDA grants orphan drug designation to EDV nanocells for glioblastoma multiforme
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The FDA granted orphan drug designation to epidermal growth factor receptor–targeted, doxorubicin-loaded EDV nanocells for the treatment of glioblastoma multiforme, according to the drug platform’s manufacturer.
The bacterially derived EDV nanocell platform (EnGeneIC Dream Vector, EnGenicIC) is a first-in-class, cyto-immunotherapy technology designed to directly target and effectively kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system’s natural antitumor response.
“We are pleased that the FDA has granted orphan drug designation to our targeted EDV nanocells for the treatment of glioblastoma multiforme, a difficult-to-treat cancer indication with an especially poor prognosis,” Jennifer MacDiarmid, PhD, joint CEO and director of EnGeneIC, said in a company-issued release. “This is not only an important U.S. regulatory milestone, but an exciting step towards our U.S. clinical advancement.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.