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Warnings Sought for Procrit, Aranesp in Europe

Jun 27, 2008 | Parker Waichman LLP European regulators want tougher warnings for Procrit and Aranesp, similar to those recently added to the drugs in the United States.  On Thursday, a European Medicines Agency (EMEA) panel recommended blood transfusions to treat anemia rather than the drugs, saying the risk of tumor progression and death outweighs their benefits in patients with "reasonably long life-expectancy."

Procrit and Aranesp are known as erythropoiesis-stimulating agents (ESA).  All are made by Amgen, but Procrit - marketed as Eprex in Europe - is sold by Johnson & Johnson subsidiary Ortho Biotech under a licensing agreement. In the United States, Amgen markets a third ESA, called Epogen.

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. Over the past 18 months, eight late-stage clinical trials have shown that treatment with ESAs can have an adverse impact on cancer survival.

In the United States, Amgen and Johnson & Johnson announced in March that they would be including a black box warning on the drug’s labels about their association with increased tumor growth and shortened survival time in some cancer patients.  The latest black box to be included on the labeling of Procrit and Aranesp came on the heels of the PREPARE breast cancer study. That breast cancer study was one of 5 clinical trials that Amgen had agreed to after the safety of Aranesp was called into question. The new black box cites information from PREPARE which showed patients had a higher risk of death on Aranesp. It also notes danger for patients with cervical cancer, based on results in December from a study called GOG-191.

A week later, a US Food & Drug Administration (FDA) advisory panel voted 13 to 1 in favor of allowing the continued sale of the ESAs for use in cancer patients undergoing chemotherapy. However, the panel voted 11 to 2 in recommending that the drugs not be used in cancer patients who are likely to be cured from their treatments, which suggests the drugs should only be used as part of a best-supportive care regimen for patients with advanced cancer or those expected to die from the cancer. The panel also voted 9 to 5 that the shouldn’t be used in patients with breast cancer as well as patients with head and neck cancer.

On Thursday, the EMEA's Committee for Medicinal Products for Human Use (CHMP) said it had reviewed new data from studies that showed an increased risk of tumor progression, venous thromboembolism and shorter overall survival in cancer patients who received Aranesp and Procrit.  

Following this review, the CHMP concluded that the benefits of ESA “continue to outweigh their risks in the approved indications”. However, in cancer patients with a “reasonably long life-expectancy”, the risk/benefit ratio switches and transfusions provide the best option, though the committee agreed that there is no problem of epoetin-containing medicines for the treatment of anemia in patients with chronic kidney failure.

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