Amgen gets executive summary from Cochrane Collaboration

Amgen has announced it has received a summary of preliminary results from an independent meta-analysis of patient-level data from the Cochrane Collaboration.

The analysis is from previously conducted controlled and randomised clinical studies evaluating the use of erythropoiesis-stimulating agents (ESAs) in cancer patients.

Amgen said it has submitted this summary to the relevant regulatory authorities, including the European Medicines Agency and the US Food and Drug Administration (FDA).

Included in the summary are four separate components.

These are on-study deaths and overall survival rate regardless of treatment as well as on-study deaths and overall survival rates in patients receiving chemotherapy – the only treatment with which therapy with ESAs is currently approved.

Roger M Perlmutter, executive vice-president of research and development at Amgen, said: “The Cochrane Collaboration’s analysis corroborates important information already reflected in the recently revised ESA labelling, which physicians and patients should consider when making individual treatment decisions.”

He added the company is working closely with regulators to start new studies to address ongoing questions relating to survival when ESAs are used according to current prescription information.

In March 2008, Amgen announced the intention of discussion the benefits of ESAs in cancer patients with anaemia as a result of concomitant chemotherapy at an FDA committee meeting.