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Home Industry News Amgen to discuss ESA benefit and risks at committee meeting

Amgen to discuss ESA benefit and risks at committee meeting

17th March 2008

Amgen has announced that it is to discuss the benefits and risks of treatment with erythropoiesis-stimulating agents (ESAs) in cancer patients with anaemia as a result of concomitantly administered chemotherapy at an upcoming committee meeting.

The firm will inform the oncologic drugs advisory committee of the US Food and Drug Administration that these drugs offer patients the only therapeutic alternative to transfusions of red blood cells, which have known and uncertain risks.

Amgen will also inform the committee that twice as many patients would require transfusions of red blood cells if ESAs were not available.

Together with other risk issues, it will also note that eight studies of ESAs have shown safety signals when patients were studied for experimental indications or at higher than currently labelled haemoglobin targets.

Roger M. Perlmutter, executive vice-president of research and development at Amgen, said: “ESAs provide an unequivocal treatment benefit for cancer patients undergoing chemotherapy by reducing the need for blood transfusions.”

He added that the company looks forward to holding discussions with the oncologic drugs advisory committee regarding the development of a robust risk management initiative to reduce the risks while still providing access to the benefits of ESAs.

Last week, Amgen restated its commitment to keeping both doctors and patients up to date with the most recent available information regarding the safety of ESAs.

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