Amgen Prevails: ESAs OK for Chemotherapy-Induced Anemia

Amgen and Johnson & Johnson (J&J) dodged a bullet Thursday after the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 13–1 to recommend that erythropoiesis-stimulating agents (ESAs) continue to be marketed for chemotherapy-induced anemia.

Although the recommendation is applicable to all ESAs, the vote primarily affects Amgen’s Aranesp (darbepoetin alfa) and J&J’s Procrit (epoetin alfa), which had combined sales of $3.84 billion in 2007. Procrit is identical to Amgen’s Epogen, which is used for patients with kidney disease.

ODAC also voted 8–6 that ESAs not be restricted to patients with small cell lung cancer, the only cancer type for which clinical data have demonstrated the products do not reduce overall survival.

The FDA convened the meeting as a follow-up to a similar meeting last year when the committee overwhelmingly recommended that marketing authorization for the drugs be contingent on additional clinical studies and further safety restrictions. The agency asked the committee to advise it on restricting the indications for the drugs.

Despite the recommendations supporting the drugs, ODAC voted 9­–5 to recommend that the indication sections of labeling include statements that ESAs are not approved for use in metastatic breast and head and neck cancers. In addition, the committee voted 11–2, with 1 abstention, that ESAs not be indicated for use in patients who have potentially curable cancers.