New Brain Cancer Drug Earns Orphan Status from U.S. Food and Drug Administration

U.S. health regulators have granted orphan drug status to Cell Therapeutics Inc.’s brain cancer drug — a move that sent the company’s shares up 26 percent in premarket trading, it reports. The designation was given based on preliminary data from a mid-stage study of the drug, Opaxio, for treating glioblastoma multiforme (GBM) — the deadliest and most common type of primary brain tumor in adults — the company says.

Orphan status is granted by the U.S. Food and Drug Administration to drugs that treat diseases that affect fewer than 200,000 people, and provides seven years of marketing exclusivity from the date of approval.

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