publication date: Apr. 14, 2017

Drugs and Targets

FDA removes restrictions on use of erythropoiesis-stimulating agents

FDA has removed the Risk Evaluation and Mitigation Strategy requirements for erythropoiesis-stimulating agents in patients with anemia due to associated myelo-suppressive chemotherapy.

The text of the FDA announcement follows:

Epoetin alfa and darbepoetin alfa are erythropoiesis-stimulating agents, approved for the treatment of anemia resulting from chronic kidney disease, chemotherapy, certain treatments for Human Immunodeficiency Virus, and also to reduce the number of blood transfusions during and after certain major surgeries.

ESAs work like the human protein erythropoietin, which stimulates bone marrow to make red blood cells. Epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen Inc.

In 2017, the FDA determined that the REMS, which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh its risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer.

The FDA made this determination based on an evaluation of the results of the REMS Assessments submitted by Amgen Inc., and additional FDA analyses to understand the impact of the various regulatory and other actions on the use of ESAs. The REMS Assessment showed that:

The results from surveyed prescribers demonstrate acceptable knowledge of the product risks of decreased survival and/or the increased risk of tumor progression or recurrence and the need to counsel patients about these risks.

The drug utilization data indicates appropriate prescribing of ESAs consistent with the intended use as a treatment alternative to RBC transfusion for … Continue reading FDA removes restrictions on use of erythropoiesis-stimulating agents

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