Russian regulators have approved the world's first cancer vaccine, validating an unusual strategy by its maker to introduce the product even though it failed a late-stage clinical trial.
Shares of Antigenics Inc, the tiny New York-based biotechnology company which has been developing the vaccine for 11 years, rose as much as 58 percent on the news.
It is the first time the Russian government has approved a drug that was not first cleared in its country of origin, according to Antigenics, and clears the way for the company to start generating revenue from Oncophage later this year.
The company plans to file for approval of the vaccine in Europe by the end of the year, based on a relatively new set of guidelines in that jurisdiction.
Regulators in Russia approved Oncophage based on a subset of data from a late-stage clinical trial that in 2006 failed to show the vaccine delayed the recurrence of kidney cancer.
In the subset of patients - those whose cancer was least likely to recur following surgery - Oncophage lengthened the period before which the disease recurred by 45 percent, or an average of 1.8 years, versus those in the control group.
The U.S. Food and Drug Administration does not consider subset analysis a valid measure of success or failure since all manner of sub-populations can be carved out retrospectively. Therefore the vaccine stands little chance of approval in the United States.
"What this company needs to do now is a trial based on their findings with the good prognosis patients," said Dr. Otis Brawley, Chief Medical Officer at the American Cancer Society. "If they have a positive finding at that point then I'm going to be excited, and then I believe it would go before the FDA very quickly."
Conducting such trials, however, could take up to 10 years and vast sums of money, and would take the product's development cycle to 20 years.
"No one in their right mind would authorize that," said Garo Armen, the company's chief executive, in an interview. "Even if we had the money it wouldn't be practical."
SEEKING BROAD APPROVAL
Unlike their U.S. counterparts, Russian regulators have accepted the validity of the subset - in part because roughly a third of the 604 patients enrolled in the late-stage trial were tested in Russia, and about 70 percent of those fell into the subset of patients whose prognosis following surgery was better than that of the total population.
Antigenics thinks it will be able to win approval elsewhere in the world too.
