Verastem: FDA Grants New Mesothelioma Orphan Drug Approval to VS-5584

Mesothelioma patients may see a potential new treatment option in another drug that targets and kills cancer stem cells. Drugmaker Verastem Inc. this month announced the U.S. Food and Drug Administration (FDA) granted VS-5584 — a drug that can reduce cancer stem cells efficiently — an orphan drug designation for mesothelioma. Last month, the drug received similar status in Europe. "We look forward to taking full advantage of the opportunities in order to bring this potential new treatment option to patients as rapidly as possible," Verastem CEO Robert Forrester said. "This is an important regulatory milestone." While Forrester announced the FDA's orphan drug approval, the federal regulatory agency has not released an official confirmation on VS-5584. "FDA cannot confirm the existence of or comment on any current/pending product applications," agency spokeswoman Lyndsay Meyer said. "The FDA is only able to provide information on approved drug product applications." The FDA grants orphan drug designation to products that treat a rare disease or condition when requested by the manufacturer. The drug and condition must meet certain criteria. The designation often helps the development of experimental drugs for rare cancers by giving the manufacturer exclusivity for an extended period and critical tax credits. Mesothelioma is a rare disease caused by prolonged exposure to asbestos. Stem Cells Are Key to Cancers Although cancer stem cells comprise only a small portion of cel...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Tags: Treatment & Doctors Source Type: news