FDA OKs 'Vaccine' To Treat Prostate Cancer

The Food and Drug Administration on Thursday approved a "vaccine" to treat prostate cancer.

Provenge, developed by Dendreon Corporation, is the first approved "treatment that uses a so-called cancer vaccine, a drug that trains the body's own immune system to fight the disease," The New York Times reports. "In clinical trials it extended the lives of patients about four months compared with a placebo. Getting the immune system to attack cancer has tantalized scientists for decades, because it promises to have fewer side effects than the harsh chemotherapy now used. But until now the approach has yielded little but disappointment. ... A full treatment will cost $93,000. Dendreon officials defended that price, saying it was in line with those of other cancer drugs in terms of cost per extra month of life provided by the drug" (Pollack, 4/29).

The Associated Press: "Experimental vaccines to treat other cancers — including the deadly skin disease melanoma and an often fatal childhood tumor called neuroblastoma — are in late-stage development. ... The treatment is intended for prostate cancer that has spread elsewhere in the body and is not responding to hormone therapy. Medical specialists hailed the approval as a milestone, but stressed the therapy be an addition to current medical practice, not a replacement. … Company studies showed taking Provenge added four months to the lives of men with advanced prostate cancer — more than the three months afforded by Taxotere, the only chemotherapy approved for men in this situation" (Perrone, 4/30).

USA Today: "A February analysis by J.P. Morgan estimates that Provenge has the potential for blockbuster sales of $1.5 billion a year. A growing number of health economists and patient advocates have expressed concern about the skyrocketing cost of cancer drugs. Many health plans are raising out-of-pocket costs to help cover these expenses, research shows. When cancer drugs get too expensive, patients simply abandon them, researchers found. A study presented in April at the Academy of Managed Care Pharmacy's annual meeting found that 29% of cancer patients with $500 or more a year in out-of-pocket costs stopped filling their prescriptions" (Szabo, 4/30).

ABC News: "Considering how few treatment options are available for men at that time, some doctors worried whether there would be enough access to Provenge in future months. At the same time, others worried that more men would want Provenge than would be eligible for treatment. … Barri Winiarski, a spokeswoman for Dendreon Corp., the company that makes Provenge, said the company would be able to treat 2,000 patients within the first 12 months. The company's single manufacturing facility for Provenge would be running by early 2011 and two more sites in California and Georgia would be open by mid-2011" (Cox, 4/29).

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