Cancer Drug Spurned in U.S. Approved

Antigenics, the maker of a drug that stimulates the immune system against kidney cancer, won approval to market the product in Russia after a study failed to meet the statistical standard in the United States.

The Health and Social Development Ministry cleared Oncophage for patients with an intermediate risk of cancer returning after surgery to remove kidney tumors, the New York-based company said in a statement. Before it can sell the product, Antigenics needs an export license from the U.S. Food and Drug Administration. The company expects the FDA to act within 60 days.

Oncophage failed to lower the overall risk of relapse in a trial of 604 patients, although it helped 60 percent of people stay in remission longer if they had an intermediate risk of recurrence. Such a "subset analysis" of patients is not accepted in the United States, so Antigenics applied to sell the drug in Russia, and will ask European regulators this year. Oncophage, the company's first product, may generate $100 million in sales, Antigenics said.

"This is a historic development," Antigenics chief executive Garo Armen said. "The world may not see it that way, but this is the first approval of a personalized cancer vaccine in any major geography. Our product prevents a substantial number of patients from entering a crisis mode."

Oncophage will be priced in the "low-to-mid range" for new cancer drugs, which cost $50,000 to $70,000 for a course of treatment, Armen said. The current standard of care for kidney cancer patients involves surgically removing tumors and observation, so Oncophage will not face any pharmaceutical competition, he said.

Antigenics will market the product itself with a three-person contract sales force in Russia, he added.

If Oncophage becomes a commercial success, it could change the way cancer is treated, Armen said. Oncophage is designed to work more effectively at earlier stages of disease, instead of waiting until the disease has spread. Most drug makers concentrate on patients near the end of life, because clinical trials do not take as long to show a benefit, Armen said.

Oncophage is part of a class of "cancer vaccines" that stimulate the body's immune system to fight tumor cells like a virus. The company persuaded Russian regulators to look favorably on results from 362 patients with intermediate risk of relapse of 604 total patients in the clinical trial.

One-fourth of the patients in the study were from Russia, Antigenics said.

The FDA usually rejects subset analyses as "fishing expeditions," Armen said in an interview in May.

"The reason the company went to Russia is there's a perception, if not the reality, that the regulatory body there is more lax," said Christopher Wood, a urologist at M.D. Anderson Cancer Center in Houston, and lead investigator of the Oncophage trial.

"That said, based on my evaluation of the data, there is evidence here that this is an active agent for patients with intermediate risk of relapse."