FDA Reviewing Anemia Drugs Again

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Main Category: Blood / Hematology
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 04 Jan 2008 - 2:00 PST

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The US Food and Drug Administration (FDA) said it is reviewing new data on the risks of a type of anemia drug called ESAs, erythropoiesis-stimulating agents.

The evidence comes from two studies that found patients with breast or advanced cervical cancer who were given ESAs for chemotherapy-induced anemia died earlier or their tumours grew faster than similar patients who did not take ESAs.

The FDA advised stronger warnings for ESA use with cancer patients in November last year following the evidence of six studies giving similar results. These two new studies were not among them.

According to the FDA, all 8 studies, when viewed together, show patients with certain types of cancer die earlier and have faster tumour growth when they are given ESAs compared to patients who do not take the drugs. The particular types of cancer are: breast, non-small cell lung, head and neck, lymphoid and cervical.

The ESAs were given in order to help the patient get to a a hemoglobin level of 12 g/dL (grams per deciliter) or more, but, said the FDA, many of them did not get to that level.

The FDA is planning to hold a public advisory committee meeting within the next few months to go through the evidence and discuss the risks and benefits of ESAs for patients with chemotherapy-induced anemia.

FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, Dr Janet Woodcock said the new data:

"Further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications."

"FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients," she urged.

ESAs are an artificial version of a protein that occurs naturally in the kidney and triggers the bone marrow to make more red blood cells.

Doctors measure patients' hemoglobin (an iron-rich protein in red blood cells that carries oxygen) to find out how anemic they are and decide whether to prescribe ESAs.

ESAs are approved by the FDA for treatment of anemia in patients with chronic kidney failure and chemotherapy-induced anemia. They are also FDA approved for treatment of HIV patients whose anemia is caused by the drug AZT (zidovudine) and to reduce the number of transfusions needed either during or after major surgery.

The FDA has approved three ESAs: Aranesp, Epogen, and Procrit, all made by Amgen, who are based in Thousand Oaks, California. Procrit is also marketed and distributed by a subsidiary of Johnson & Johnson called Ortho Biotech LP who are based in Bridgewater, New Jersey.

The first of the two new studies was given to the FDA by Amgen on 30th November last year. This study, called the PREPARE study, included 733 women who had been treated with chemotherapy before having surgery for breast cancer. The trial compared patients who were given Aranesp for anemia with patients who did not take the drug.

After 3 years 14 per cent of the Aranesp patients had died compared to 9.8 per cent in the non-Aranesp group. The tumours of the Aranesp patients also grew faster.

Amgen gave the FDA the results of the second study on 4th December. This study was part of the National Cancer Institute's Gynecologic Oncology Group, where patients received chemotherapy and radiation therapy for advanced cervical cancer.

These patients were either given Procrit to reach a hemoglobin count of 12 g/dL or more, or they were given blood transfusions.

After 3 years, 58 per cent of the Procrit group were alive, compared with 66 per cent of the non-Procrit group.

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Sources: FDA ongoing safety review communication.

Written by: Catharine Paddock
Copyright: Medical News Today
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