ESA Risk Mitigation Strategy Requires Training, Patient Consent, Documentation

From The Cancer Letter, Feb. 19, 2010:

FDA has approved a “risk evaluation and mitigation strategy” for erythopoiesis-stimulating agents for chemotherapy-related anemia.

The measures, known under the acronym REMS and mandated two years ago by the FDA Oncologic Drugs Advisory Committee, require additional training and certification for healthcare providers as well as distribution of a “medication guide” for patients who may be receiving these agents.

For the rest of the story, click on The Cancer Letter Archive at left to read the Feb. 19 issue (subscription or day pass required).

Also in this issue: FDA’s Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

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tags: FDA