ROCHE SUSPENDS RECRUITMENT IN ANEMIA DRUG STUDY AFTER DEATHS

Roche has temporarily suspended recruitment in a study of anemic advanced lung cancer patients receiving chemotherapy after an "imbalance" of deaths across the four arms of the study, the company announced.

Three of the arms involved Roche's investigational anemia drug C.E.R.A. and the fourth used Amgen's anemia drug Aranesp, Roche said. Amgen recently terminated an experimental study after finding that Aranesp led to a higher death rate than placebo in cancer patients.

While Roche did not reveal the number of deaths, it said they were partially driven by the progression of the underlying cancer.

Patients already enrolled in Roche's study will continue receiving treatment throughout the 12-week study period, the company said. Although study investigators maintained that all the deaths were unrelated to the drugs, an independent drug safety monitoring board recommended the suspension of enrollment.

Roche had not seen a similar type of imbalance in three previously completed studies with C.E.R.A. use in cancer patients, the company said. Roche added it saw no association between the deaths and excessive hemoglobin levels.