What Will ODAC Do?

The Oncology Drugs Advisory Committee of the Food and Drug Administration is meeting in suburban Washington today to offer its take on whether erythropoietin-stimulating drugs like Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit pose an unacceptable risk to cancer patients. The FDA and the firms sent this change in its warning label to doctors yesterday:

WARNINGS: . . . the results of two additional studies (show) increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.

That level -- 12 g/dL or a hematocrit of 36 -- is well above a safe target level for eliminating the need for blood transfusion in cancer chemotherapy patients. That is about 10 g/dL. For years, both companies have spent lavishly on direct-to-consumer advertising claiming that taking these drugs will keep up your strength during chemotherapy.

Yet those claims are not supported by strong evidence. Indeed, an FDA reviewer at a previous ODAC meeting dismissed these studies as unanalyzable because their instruments -- patient surveys -- were of such low quality.

At the end of the day, it will be interesting to see if the ODAC chooses to elevate patient safety over poorly documented claims that patients feel better with higher red blood cell counts. And if they do, it will be even more interesting to see if the FDA bites the bullet and orders a more restrictive label.