FDA Panel Votes to Limit ESA Cancer Use to Metastatic Patients
FDA Panel Votes to Limit ESA Cancer Use to Metastatic Patients
B Marson
20080217
2008 Mar 17
The Pink Sheet Daily
FDA Panel Votes to Limit ESA Cancer Use to Metastatic Patients
The Pink Sheet Daily. 2008 Mar 17, B Marson
Following the recommendations of its Oncologic Drugs Advisory Committee, FDA's next step in ensuring the safe use of erythropoiesis-stimulating agents will be to determine how best to narrow the approved indication for anemia treatment in the cancer setting. The committee, which met March 13 to re-evaluate the totality of ESA safety data, voted overwhelmingly that Amgen's Aranesp (epoetin alfa) and Johnson & Johnson's Procrit (darbepoetin alfa) should continue to be marketed for chemotherapy-induced...