Following earlier warnings of an increased risk of death to cancer patients taking Aranesp, leading biotechnology company Amgen has now said the medication is safe when given for approved uses, and poses chemotherapy patients no greater risk of dying.
Citing a company-sponsored, double-blind, placebo-controlled Phase III study of 600 patients with advanced small cell lung cancer receiving chemotherapy, Amgen said the drug “showed no statistically significant difference in risk of death”. The company also said patients taking Aranesp (dabepoetin alfa) showed an increased red blood cell count and a reduced need for blood transfusions, both of which indicate success in treating anaemia.
The latest results may help to reassure patients and healthcare professionals that Aranesp is safe for the treatment of patients with chemotherapy-induced anaemia. Commenting on the results, Eric Schmidt, an analyst with Cowen & Co, said, “it removes the worst-case scenario. The drug isn't going away.”
Aranesp is approved to treat anaemia associated with chronic kidney disease. In July 2002, it was also given approval for weekly dosing for the treatment of anaemia in patients with nonmyeloid malignancies where anaemia results from chemotherapy, and in March the US Food and Drug Administration approved three-week dosing in these patients.
However, in January Amgen reported that cancer patients not receiving chemotherapy or radiation had a higher risk of dying if treated with Aranesp. The full results from this study released last week showed that one in four cancer patients given Aranesp died after 19 weeks. A higher incidence of death in patients taking Aranesp was also reported in a Danish study of head and neck cancer patients undergoing radiation. The FDA issued a black-box warning for Aranesp and other erythropoieses-stimulating agents.
Findings from the previous studies led to a 12% drop in the value of Amgen’s stock.
Amgen hopes the latest results may help to reassure investors that Aranesp is safe when used for approved indications. The company delayed reporting its first-quarter earnings until April 23, so it could release the results from the latest lung-cancer study. The positive findings appear to have had some effect. Amgen stock rose by 5.2%, to $63.14 on announcement of the new results.