FDA approves Provenge for treating men with advanced prostate cancer

May 6 2010

US government approves prostate cancer treatment vaccine

The US Food and Drug Administration (FDA) has approved a new 'cancer vaccine' for treating men with advanced prostate cancer.

Provenge (sipuleucel-T) has been approved for prostate cancer patients with few or no symptoms whose disease has spread to other parts of the body and who are not responding to hormone treatment.

It is a new type of treatment called immunotherapy, which stimulates the patient's own immune system to fight the cancer.

Immune cells are extracted from the patient's blood by a process called leukapheresis. The cells are then exposed to a protein found on prostate cancer cells to enhance their response against the cancer.

They are then returned to the patient via a drip, with three doses given at two-week intervals.

A trial involving 512 patients with advanced prostate cancer found that those who received Provenge typically survived for around four months longer than those who were not treated with the vaccine.

Side-effects such as chills, fatigue, fever, back pain and nausea were common, but tended to be mild.

Dr Karen Midthun, acting director of the FDA's Center for Biologics Evaluation and Research, said: "The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available."

Dr Chris Parker, a Cancer Research UK-funded prostate cancer expert at The Institute of Cancer Research, commented: "This is exciting news for the field of immunotherapy. It's the first time that any immunotherapy has been shown to increase survival for prostate cancer. Hopefully, this approval will open new avenues of research into using a patient's own immune system to treat cancer.

"The process for approving drugs in the UK is different from the US, so this treatment is not yet available here," he added.

Source: Cancer Research UK