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Home Industry News Amgen announces interim Aranesp results

Amgen announces interim Aranesp results

3rd December 2007

Amgen has announced interim results of its phase III clinical study of Aranesp (darbepoetin alfa) as a treatment for breast cancer, with patients receiving dose-dense dose-intense preoperative chemotherapy, rather than a standard preoperative regimen of chemotherapy.

The interim results showed that there is no significant difference between the Aranesp patient arm and control groups.

Data available by the end of October show numerically more deaths and tumour progression events in patients receiving Aranesp compared to the control group in the long-term follow up, while a formal analysis of the figures for survival is forecast for early 2009.

Professor Michael Untch, of the German Gynaecological Oncology Study Group, said: “This interim analysis shows that the use of Aranesp to support neo-adjuvant chemotherapy has no significant impact on tumour response to chemotherapy at the time of surgery.”

He added that researchers should not draw definitive conclusions from the long-term follow up assessment until the final study report is finished, while noting an absence of deaths during the treatment period for the compound.

In September 2007, Amgen announced that Aranesp had been approved in the European Union to treat paediatric patients either on or not on dialysis suffering from chronic renal failure.

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