SAN FRANCISCO -- One in four cancer patients given Amgen Inc.'s Aranesp anemia drug in a study died after 19 weeks, a rate about 5 points higher than among those on a placebo, a finding likely to make doctors more cautious about the product.
Researchers released new details yesterday about the study of 851 cancer patients. The mortality rate was 49 percent after two years, compared with 46 percent for the placebo, the scientists said in Los Angeles. The drug failed in the study to reach its goal of reducing blood transfusions, according to the report.
While Aranesp is the world's top-selling drug to treat anemia, the trial may prevent Amgen from winning approval to market the product for use in cancer patients not receiving chemotherapy .
"This is potentially a practice-changing study," said David Steensma, a hematologist at the Mayo Clinic in Rochester, Minn., who wasn't involved with the study. "People are going to become more cautious in this setting."
Amgen earlier said the study had found "a statistically significant increased risk of death" associated with the drug, prompting the company's shares to fall 4.5 percent on Jan. 26, the most in more than a year.
The Food and Drug Administration plans to gather an expert advisory panel to discuss the results on May 10. The agency's current advice to doctors is to use the lowest dose possible, in approved applications, to help patients avoid blood transfusions.
Of 419 patients on the drug, 136 were dead after 19 weeks and 250 after two years, according to the study. Of 432 patients on the placebo, or inactive medicine, 94 died within 19 weeks and 216 were dead after two years.