Cancer Research Lab

Amgen Inc.’s anemia drug Aranesp (darbepoetin alfa) is facing further safety concerns after a medical newsletter reported on Friday that a Danish study of the drug in head and neck cancer was halted due to adverse outcomes.

The report in The Cancer Letter said the study was temporarily halted in October after an interim analysis of the first 484 patients turned up a statistically significant increase in disease recurrence. It said a decision not to resume the study was made on Dec. 1.

Amgen said it has not seen the complete data from the study that was conducted by the Danish Head and Neck Cancer Group, but added that it informed the U.S. Food and Drug Administration of the trial’s suspension within 24 hours of receiving preliminary data.

Amgen did not disclose the information to analysts and investors during a Jan. 25 conference call on its quarterly results. “We received only preliminary and incomplete safety data,” an Amgen spokeswoman said. “We don’t generally comment on third-party reports.”

It was during that Jan. 25 call that Amgen revealed a statistically significant increased risk of death seen in a different study of cancer patients not undergoing chemotherapy who were treated with Aranesp.

There has been some speculation that the drug, in boosting production of red blood cells, may be feeding malignant tumors.