Dendreon’s Provenge Approval Sparks New Era for Cancer Vaccines

Dendreon Corp. won approval for its only product, the prostate cancer vaccine Provenge, concluding a three-year battle with U.S. regulators to introduce the first therapy to train the body’s immune system to destroy tumors.

Provenge may reap annual sales of $4.3 billion by 2020, said George Farmer, a Canaccord Adams Inc. analyst in New York. Its clearance will also benefit more than a dozen other companies developing drugs in the emerging field of cancer immunotherapy, said Joseph Pantginis, an analyst with Roth Capital Partners in New York.

“This approval represents the first cancer immunotherapy product approved in the U.S. and is truly a landmark event,” Pantginis said in a research report yesterday.

Provenge, cleared yesterday for use against advanced prostate tumors, will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011, Seattle-based Dendreon said in a statement. It will cost $93,000 for a typical three- dose course of treatment, the company said.

Food and Drug Administration approval of Provenge “will definitely inform the clinical development programs of other companies” working on vaccine treatments for cancer, said Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston, in a telephone interview before the decision was announced.

The most advanced of these vaccines include Seattle-based Oncothyreon Inc. and German drugmaker Merck KGaA’s Stimuvax for breast and lung malignancies; ipilimumab from Bristol-Myers Squibb Co. of New York, for melanoma; and British drugmaker Oxford BioMedica Plc’s TroVax for prostate and kidney cancer.