Federal actions taken in May could lead to curtailed use of biologics for treating anemia associated with certain cancers.
On May 10, members of the Oncologic Drugs Advisory Committee of the US Food and Drug Administration (FDA) voted 15 to 2 in favor of recommending new restrictions on the use of genetically engineered erythropoiesis-stimulating agents (ESAs) in patients with cancer. The advisory committee also voted (17 to 0) to call for new safety studies for ESA use for patients with cancer.
The drugs under scrutiny are darbepoetin alfa (Aranesp, made by Amgen Inc, Thousand Oaks, Calif) and epoetin alfa (Epogen, made by Amgen, and Procrit, made by Johnson & Johnson, New Brunswick, NJ).
Just 4 days later, the Centers for Medicare & Medicaid Services (CMS) announced a proposed decision to limit coverage of ESA treatment for patients with certain cancers and related neoplastic conditions. The agency said this . . . [Full Text of this Article]
