[OT] FDA OKs Provenge for Prostate Cancer Therapy

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BlankFDA OKs Provenge for Prostate Cancer Therapy

'Vaccine' Is an Immune Therapy That Treats Advanced Prostate Cancer

By J. DeNoon

WebMD Health News

Reviewed by J. , MD

April 29, 2010 -- The FDA today approved Provenge, Dendreon Corp.'s

individualized " vaccine " for the treatment of advanced prostate cancer.

The action comes more than three years after an FDA advisory panel recommended

approval, declaring the immune therapy safe and effective. But FDA concerns over

efficacy led the FDA to delay a decision until more data became available.

Provenge doesn't cure prostate cancer or prevent it from getting worse over

time. But it does extend survival -- by months for most patients, by years for

some.

Provenge isn't your everyday vaccine. It's an immune therapy created by

harvesting immune cells from a patient, genetically engineering them to fight

prostate cancer, and then infusing them back into the patient.

It's approved only for treatment of asymptomatic or minimally symptomatic

patients with prostate cancer that has spread outside the prostate and no longer

responds to hormone therapy.

In clinical trials, Provenge extended survival by a median 4.1 months -- about

half of patients were below that amount and half were above. But some of the

patients remain alive years after the treatment. In the most recent trial, 32%

of Provenge-treated patients remained alive three years after treatment. Only

23% of placebo-treated patients survived that long.

The approval makes Provenge the first cancer treatment vaccine. It will

" re-energize " work in a field that is littered with disappointing failures, says

Dreicer, MD, chairman of Cleveland Clinic's department of solid tumor

oncology. Dreicer helped run a Provenge clinical trial but has no financial

interest in the product.