Provenge FDA Approval Granted for Prostate Cancer Treatment

Provenge FDA Approval Granted for Prostate Cancer Treatment

On April 29, 2010, the FDA approved Provenge, a drug originally slated as a prostate cancer vaccine, as a treatment for use on advanced prostate cancer patients. Although the drug neither prevents, nor cures prostate cancer, the drug was shown to extend the lives of men with advanced prostate cancer by four months. Patients now have an alternative to the physically taxing chemotherapy frequently used to combat the disease.

What’s Different About the Way Provenge Works?

What’s Different About the Way Provenge Works

Provenge is labeled as a vaccine, because it uses the patient’s own immune system to target and attack cancer cells. It’s the first autologous cellular immunotherapy drug of its kind to be approved by the FDA. The approval comes after decades of research, development, and clinical trials.

The drug is actually made from the patient’s own immune cells, thus making it a unique therapy. First, cells are extracted from the patient, followed by the addition of a special protein to the cells. Finally, the cells are reinfused into the patient. The treatment elicits an immune response from the body in order to counteract the prostate cancer. Reported side effects are mild in comparison to chemotherapy.

Provenge’s Limited Supply and Time-Consuming Therapy Formulation Process

Since Provenge therapy is tailored to each patient, and cannot be stored, the manufacturing capacity is limited. In addition, the therapy formulation process is time consuming. Currently, Dendreon expects to provide therapy for 2,000 patients within the next year. The price tag for the therapy is $93,000 per patient, and it is unclear whether health insurance companies will cover the cost of the treatment, click over here.

The patients who will receive the prostate cancer vaccine during the first year are slated to come from the 50 centers across the nation that participated in the clinical trials. Dendreon intends to increase the manufacturing capacity over the next 12 months to support treatment for additional patients in order to meet the demand for the drug. Analysts expect the company to reach over $1 billon in sales by 2016.

Therapy Formulation Process

According to FDA reports, approximately 192,000 men were diagnosed with prostate cancer in 2009, with 27,000 men dying from the disease. Based on the clinical studies involving Provenge, the drug will help to extend the lives of patients who receive the therapy. Additionally, Dendreon hopes to more widespread use of the drug will lower costs, as well as make the drug available to more people who need it. Other vaccine manufacturers are hopeful that similar drugs to treat other types of cancers will receive future FDA approval as well.