First Cancer Vaccine Cleared by the FDA

The first cancer vaccine, known as Provenge, was approved today by the Food and Drug Administration. The move was a victory for the drug’s creator, biotechnology company Dendreon: Provenge had originally being rejected by the FDA, and was kept in development limbo for three years.

Provenge is a kind of cell therapy developed by Dendreon to treat prostate cancer, and the first of it’s kind found to be effective. During treatment, cancerous cells are taken from the patient, mixed with vaccine, and then injected back into the body. This process primes the body itself to fight the disease like a virus, with the side effects being, so far, only chills, fever, and headache.

The drug was initially submitted for approval back in November 2006, but was forced by the FDA to undergo further testing in 2007. During the later and larger study, 512 cancer patients were treated with the drug, and lived 4.1 months longer than those on placebo. This proof was the cornerstone for today’s approval.

However, it’s important to note that this is a treatment, not a cure. Four months isn’t a long time, and therapy is tailored toward those with established and advanced cancer. Moreover, the pricetag is high, currently costing more than $90,000. But it’s a start; it offers an alternative to the more than 30,000 people suffering from the disease, making Dendreon confident that it will be a success when it’s released. Also, though it’s the first, it isn’t the only player on the block. Other cell therapy treatments are being developed by other companies around the world. But with their stock skyrocketing following the announcement, right now, Dendreon has much to celebrate.

[via Forbes, BusinessWeek, Reuters]