FDA Approves Orphan Drug Status for Pancreatic Cancer Vaccine

Yael Waknine

March 18, 2010

March 18, 2010 — The US Food and Drug Administration (FDA) has approved orphan drug status for a therapeutic vaccine (GVAX, BioSante Pharmaceuticals, Inc) to treat pancreatic cancer.

Pancreatic cancer is often diagnosed at a late stage because of lack or inconsistency of symptoms, and median survival generally ranges from 3 to 6 months. Because of this poor prognosis, new and effective treatments are urgently needed.

The pancreatic cancer vaccine is composed of tumor cells that are genetically engineered to produce granulocyte macrophage colony-stimulating factor, which is a crucial growth and activation factor for antigen-presenting cells that play a vital role in the initiation of systemic immune response.

Secretion of granulocyte macrophage colony-stimulating factor therefore stimulates the patient's immune system against the vaccine's cells, and antigen similarity encourages activity against the original cancer.

Lethal irradiation of the vaccine tumor cells precludes cell division and cancer spreading.

According to a company news release, ongoing trials at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, are evaluating the safety and benefit of adding pancreatic cancer vaccine to other anticancer agents alone or with other drugs.

Other potential indications for GVAX vaccines include leukemia and breast cancer.

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