Oncophage Gets FDA Fast Track Designation.(Brief Article)

2001 NOV 14 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has designated Oncophage, Antigenics Inc.'s personalized cancer vaccine, a fast track product for the treatment of renal cell carcinoma.

Under the FDA Modernization Act of 1997, designation as a fast track product means FDA will take appropriate actions to expedite the development and review of an application for approval. Fast track designation is granted to products determined by the agency to treat a serious or life-threatening condition and have the potential to address an unmet medical need.

In the FDA's letter to Antigenics, the agency stated that it is "designating as a fast track development program the investigation of Autologous Tumor-Derived gp96 Heat Shock Protein-Peptide Complex (HSPPC-96, Antigenics) for its superior effect on survival as an adjunct to surgical resection of renal cell carcinoma compared to no additional postsurgical treatment."

Oncophage is the first personalized cancer vaccine to receive fast track designation. Antigenics received the designation in approximately half the time allotted by the FDA to make a determination.

"Receiving fast track designation is an important milestone for the development of Oncophage," said Russell Herndon, COO of Antigenics. "Oncophage is one of the most unique cancer treatments currently under development, representing years of research, groundbreaking discoveries and clinical breakthroughs. Antigenics' goal has always been to treat cancer while allowing patients to enjoy a good quality of life. We look ...