Prostate cancer vaccine gets FDA approval

The U.S. Food and Drug Administration approved Provenge, a novel technique for fighting prostate cancer, on Thursday. The treatment involves taking a patient’s own white blood cells and using a drug that trains them to more actively attack cancer cells.

The treatment is intended only for men with so-called “metastatic castration-resistant” prostate cancer, for whom hormone suppressant therapy has not worked. Studies have shown that Provenge prolongs survival by about four to 4.5 months.

“It’s a landmark in the sense that it would be the first approved cell-based immune therapy,” said Dr. Nina Bhardwaj, director of the tumor vaccine program at New York University Langone Medical Center, who is not involved with Provenge or its maker, Dendreon Corp.

But the real breakthrough is the approval of this new way of treating disease, which could be used for other cancers and conditions, such as HIV, Bhardwaj said.

“It’s a major conceptual advance; it’s a modest therapeutic advance,” said Dr. Christopher Logothetis, prostate cancer researcher at the University of Texas M. D. Anderson Cancer Center. Logothetis testified to an FDA panel in 2007 about the drug, but has no financial ties to Dendreon.

It is unclear whether insurance companies will cover the cost of Provenge and it may be prohibitively expensive for some, Bhardwaj said. Dendreon says it will be priced similarly to other new biologics that prolong survival.

Investment firm J.P. Morgan estimates a full course of Provenge will cost $65,000; estimates by other investors put it between $50,000 and $100,000, according to J.P. Morgan. Cancer drugs Avastin and Erbitux, also based on new concepts in treating different kinds of cancer, cost up to $100,000 per year.

“In this whole scheme of things, Provenge is costly, but not unheard of,” Bhardwaj said.

Provenge is the first cancer treatment vaccine that the FDA has approved.