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FDA turns down Advaxis orphan drug request


NORTH BRUNSWICK, N.J. The Food and Drug Administration has denied a biotech company’s request for a special designation for a drug it is developing to treat invasive cervical cancer.

Advaxis said Wednesday that it had received a letter from the FDA denying its request for orphan drug designation for ADXS11-001. The FDA grants the designation for drugs that treat diseases affecting fewer than 200,000 people, though the agency told Advaxis that the disease exceeds the 200,000-person cutoff, including people who have been cured.

“When we announced this ODD filing, we said it was historically a 50% probability of getting approved,” Advaxis chairman and CEO Thomas Moore said. “With an annual incidence of only 10,000 patients in the U.S. diagnosed with invasive cervical cancer and a very poor prognosis if standard therapies fail, which they do for about half these patients, this appeared to be just what orphan drug was designed to encourage.”

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