Provenge (sipuleucel-T) vaccine for prostate cancer to cost $50,000

Dendreon’s Provenge, which is found to prolong survival, could be the 1st therapeutic vaccine against cancer.

Provenge, a new drug from Dendreon Corp, can well become the first approved therapeutic vaccine for any type of cancer.

Late phase human studies with Provenge has shown that the new medicine improved survival in men with advanced forms of prostate cancer.

Following the announcement, shares of Dendreon more than tripled in the bourses.

Provenge, if approved, is going to be the first therapeutic vaccine — vaccines that prevent disease, unlike traditional vaccine. Dendreon’s Provenge medicine treats it by stimulating the body’s own immune system.

Besides, Provenge has also prolonged the chances of survival after afflicted with prostate cancer.

However, Provenge can be very costly, as well. OrbiMed’s Borho predicted Provenge, which is administered only once, would cost more than $50,000.

Provenge data from the Phase III clinical trial met the main study goal of improving survival. This made Dandreon to announce that the company would seek U.S. regulatory approval –Biologic License Application (BLA) –of Provenge in the fourth quarter.

“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” Dendreon Chief Executive Mitchell Gold said in a statement.

The study included 512 men with late-stage prostate cancer who have not benefited from drugs that sharply lower testosterone — the male sex hormone that fuels progression of the cancer.

The multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment)  was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).

Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association’s Annual Meeting in Chicago on Tues., Apr. 28, the company statement said.

“Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival,” said  Gold.

“We are immensely grateful to our clinical investigators and the more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies.”

To make the product, a fragment of the patient’s tumor is sent to a laboratory, which isolates specific proteins linked to the cancer and incorporates them into the vaccine. Once injected, the body’s immune system seeks out and destroys cells containing the target proteins, On a conference call with analysts.

An outside advisory panel of doctors recommended in March 2007 that the U.S. Food and Drug Administration approve Provenge, based on favorable efficacy and safety results from an earlier Phase III study.

But the FDA declined to approve the medicine until data from the IMPACT study confirmed earlier trends.

Provenge stood to be a $200 million product if it is approved only in the advanced prostate cancer patient group, but could expand to a $1 billion blockbuster if it is expanded to men with earlier stages of the disease, according to analysts.

Dendreon plans to market Provenge on its own in the United States, but it said it remains interested in a marketing partner overseas.

Provenge, which contains sipuleucel-T represents the first product in a new class of active cellular immunotherapies (ACIs).  In controlled clinical trials, the most common adverse events were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade with a short duration of 1-2 days following infusion.

The leading current treatment for advanced prostate cancer is Taxotere, a Sanofi-Aventis, a chemotherapy that can cause harsh side effects, including neuropathy, hair loss, nausea and vomiting.

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer. 

Head quartered in Seattle, Washington, Dendreon Corporation is a biotechnology company which targets cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia.