Dendreon’s Provenge vaccine now awaits the F. D. A.’s decision following the advisory panel hearing in Washington D. C. March 29.

Provenge is intended as the first treatment of its kind to stimulate a patient’s own immune system against prostate cancer. If it’s approved, analysts say it could generate up to $1 billion in annual sales.

Provenge is made for each individual patient. Scientists take the patient’s own white blood cells, mix them with a genetically engineered protein and reintroduce them into the patient. Specifically, blood is drawn from the patient and dendritic cells are extracted from the blood and loaded in the laboratory with a recombinant fusion protein consisting of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony-stimulating factor (GMCSF). This product is infused into the source patient at repeatable intervals; during trials, patients received uo to 3 infusions of vaccine.

In two studies, as we reported March 28 in covering F. D. A.’s questions to its advisory panel, the company failed to demonstrate the product could slow the
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