Prostate cancer vaccine wins US approval

A "vaccine" which harnesses the body's own immune system to fight prostate cancer has been approved for use by US drug regulators.

Provenge - which is designed to be used in men with advanced disease - is the first of its kind to be accepted by the Food and Drug Administration.

Each dose has to be individually tailored and it is an expensive treatment at $93,000 per patient.

It will add to, rather than replace, existing treatments, said experts.

Doctors have been working on therapies that prompt the immune system to fight tumours for decades.

Potential success stories include an experimental vaccine for melanoma which is in the late stages of development.

This latest therapy is made by collecting special blood cells from each patient that help the immune system recognise cancer as a threat.

These are then mixed with a protein found on most prostate cancer cells and a substance which kick-starts the immune response.

Advanced disease

The drug is not a "cure" but is used in advanced prostate cancer that has spread to other sites in the body and is no longer responding to standard hormone treatment.

Clinical trials showed that the treatment extended the lives of patients by four months.

This compares with an average of three months with chemotherapy.

Dr Phil Kantoff, an oncologist at the Dana-Farber Cancer Institute who helped run the studies of Provenge said: "The big news here is that this is the first immunotherapy to win approval, and I suspect within five to ten years immunotherapies will be a big part of cancer therapy in general."

Prostate cancer accounts for about 12% of male deaths from cancer in the UK and is the second most common cause of cancer death in men.

In older men aged 85 and over, the disease is the most common cause of all deaths from cancer.

John Neate, chief executive of The Prostate Cancer Charity, said: "The news that this type of immunotherapy may offer additional survival benefit is promising."

But he added: "There are still questions to answer, even if the treatment fulfils its early promise.

"At present, we believe there are currently no laboratories in Europe equipped to undertake this treatment.

"Furthermore, this treatment is not currently approved in the UK and it will still be some years before doctors know enough about its long term effectiveness and side effects to be confident about its potential place in the armoury against advanced prostate cancer."

Dr Chris Parker, Cancer Research UK's prostate cancer expert said: "We hope this approval will open new avenues of research into using a patient's own immune system to treat cancer."

FDA approves new drug for prostate cancer

Provenge trains the body’s immune system to fight the disease

WASHINGTON - A first-of-a-kind prostate cancer treatment that uses the body's immune system to fight the disease received federal approval Thursday, offering an important alternative to more intensive treatments like chemotherapy.

Dendreon Corp.'s Provenge vaccine trains the immune system to fight tumors. It's called a "vaccine" even though it treats disease rather than prevents it.

Doctors have been trying to develop such a therapy for decades, and Provenge is the first to win approval from the Food and Drug Administration. 

"The big news here is that this is the first immunotherapy to win approval, and I suspect within five to ten years immunotherapies will be a big part of cancer therapy in general," said Dr. Phil Kantoff, an oncologist at the Dana-Farber Cancer Institute who helped run the studies of Provenge.

Experimental vaccines to treat other cancers — including the deadly skin disease melanoma and an often fatal childhood tumor called neuroblastoma — are already in late-stage development.

Currently doctors treat cancer by surgically removing tumors, attacking them with chemotherapy drugs or blasting them with radiation. Provenge offers an important fourth approach by directing the body's natural defense mechanisms against the disease.

The drug is intended to treat prostate cancer that has spread elsewhere in the body and is not responding to hormone therapy.

A milestoneMedical specialists hailed the approval as an important milestone, but stressed it will serve as an addition to current practice, not a replacement.

"This is just one step in a new pathway for treating patients," said Dr. Simon Hall, chairman of urology at Mt. Sinai Hospital "We have to make them realize this isn't a cure, it's very variable."

Company studies showed that taking Provenge added four months to the lives of men with advanced prostate cancer.

INTERACTIVE Prostate cancer: What you need to know

That may not sound like a lot, but it is longer than the three months afforded by Taxotere, the only chemotherapy approved for men in this situation. Doctors hope for even greater benefit if they give the drug earlier in the course of the disease.

Dendreon would give no cost estimate for Provenge, but analyst estimates range from between $60,000 to $100,000.

The approval marks a remarkable turnaround for Seattle-based Dendreon, whose shares plummeted three years ago when the FDA delayed a decision on the therapy, asking for more proof of safety and effectiveness. That delay came despite an expert panel's recommendation for approval.

Dendreon shares jumped 19 percent to new highs ahead of the news, rising to an all-time high of $47.32. Trading of the stock was halted at 12:34 p.m. Eastern, 35 minutes before the FDA announced its decision. At the time, Dendreon shares were up $5.88, or 14.8 percent, at $45.50.

The company does not have any products on the market.

Tailored therapyAnalysts expect the product to reach blockbuster sales status — over $1 billion — by 2016, as the company expands production capacity.

Video   How prostate cancer therapy drug works   April 29: Dr. Andrew Armstrong of Duke University Medical Center shares more information on Provenge, the breakthrough prostate cancer treatment. Nightly News

Each regimen of Provenge must to tailored to the immune system of the patient using a time-consuming formulation process.

Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to rev up the immune system. The resulting "vaccine" is given back to the patient as three infusions two weeks apart.

Initially, Dendreon will identify Provenge patients through the medical centers that helped test the drug. But researchers have been told the company will only be able to provide vaccines for a few patients at each site per month.

"There are going to be a lot of patients that want it and there will be limited resources as they are getting this up and running," said Dr. Deborah Bradley of Duke University School of Medicine

About 192,000 new cases of prostate cancer were diagnosed in 2009, and 27,000 men died of the disease, according to the FDA. Prostate cancer most often affects older men.

Side effects of Provenge are relatively mild, such as chills, fatigue, fever, and headache. By comparison, side effects of chemotherapy typically include hair loss, nausea, anemia and diarrhea.