Anemia drugs may be safer for cancer patients to take than recenty thought. This week Amgen released data showing that its anemia dug Aranesp (darbepoetin alfa) did not increase risk of death when used with platinum chemotherapy by patients with extensive small-cell lung cancer (SCLC), but nor did the anti-anemia drug improve patients’ survival.

This news may allay some fears arising from a Phase III study that found that in a group patients with active cancer who were not receiving chemotherapnemia or radiotherapy, the overall number of deaths was greater in those who received Aranesp than in those who did not.

An FDA panel is scheduled to review the safety of anemia drugs on May 10.

Since January, Amgen’s stock has slipped over the excess deaths in the patients not taking chemo or radiotherapy, deaths which the company was unable to account for. John Glaspy, M.D., chief investigator of the UCLA trial, said: “Unfortunately, the benefit of ESA treatment was not observed in these gravely ill patients. Since this was not designed as a survival study and statistical significance diminished when the analyses were adjusted for known prognostic factors, there is no clear explanation for the increase of deaths in the Aranesp group.”

Epo drugs are known to raise blood pressure and risks of hearts attacks and strokes.
Doctors and patients are advised to “Use the lowest dose of Aranesp that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.”

The somewhat reasuring news comes from a randomized, double-blind, placebo-controlled, multicenter Phase 3 study of Aranesp in 600 previously untreated patients with extensive-stage small-cell lung cancer receiving platinum-containing chemotherapy. This trial “demonstrated no statistically significant difference in risk of death (overall survival Aranesp compared to placebo Hazard Ratio (HR): 0.93, 95% CI: 0.78 to 1.11)/” At the same time the trial showed no significant impact on “investigator determined progression-free survival.”

The study showed a significant change in hemoglobin concentration from baseline in favor of Aranesp. Aranesp-treated patients also experienced a significantly lower risk of blood transfusions. The overall safety profile, including thromboembolic events, was “consistent with that described in the U.S. label.”

Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen, said: “These results contribute to the growing body of evidence on ESA safety, reinforcing the neutral impact of ESAs on survival in cancer patients suffering from chemotherapy-induced anemia.”

As we noted last week, FDA. is not just concerned about the death rate in one trial. It’s re-evaluating the validity of claims on labels and in advertisements that epo drugs can raise energy levels or otherwise improve a patient’s quality of life.

According to FDA. officials the manufacturers had never demonstrated that use of Epo actually improved energy levels or quality of life for patients undergoing chemotherapy. The American Society of Clinical Oncology sent a note to its members on March 8 saying that it had learned that Medicare was cutting off reimbursement of Epo for that use, effective immediately.

For more details visit Amgen’s website.

And see earlier story, Anemia Drug May Harm Some Patients, FDA Says March 29, 2007