FDA grants orphan drug designation to Antigenics

NEW YORK The Food and Drug Administration has granted orphan drug status to an investigational treatment for a rare but deadly cancer.

Antigenics announced Thursday that the FDA had given the status for its drug Oncophage (vitespen), used to treat the brain cancer glioma. The European Medicines Agency granted a similar designation to Oncophage in March.

“Glioma is such an aggressive and challenging cancer that when patients are diagnosed with recurrence of this life-threatening disease, they rarely live beyond six months,” University of California San Francisco neurological surgery associate professor Andrew Parsa said.

Parsa is the lead investigator of a phase 2 trial evaluating Oncophage as a glioma treatment.

Data from a phase 1 trial announced in November showed that vaccination with Oncophage following brain cancer surgery increased overall median survival to more than 10 months, with four patients surviving beyond a year and one patient surviving almost two-and-a-half years. By comparison, the historical median survival rate for glioma patients after surgery is six-and-a-half months.

The FDA grants orphan drug designation to drugs used to diagnose, prevent or treat medical conditions that affect fewer than 200,000 people in the United States. The designation entitles drug makers to seven years of market exclusivity, compared to the five normally given under the Hatch-Waxman Act of 1984.