FDA's Oncologic Drugs Advisory Committee March 13 overwhelmingly concluded that erythropoiesis-stimulating agents should retain marketing approval for chemotherapy-induced anemia, but voted to restrict their use. New labeling should say the drugs are not indicated for patients with curable cancers, breast cancer or head and neck tumors, the panel said.

Both Amgen's Aranesp (epoietin alfa) and Johnson & Johnson's Procrit (darbepoetin alfa) are indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. However, product labeling has undergone several revisions as safety signals, including increased tumor promotion and decreased survival in cancer patients receiving ESAs, have emerged from postapproval studies (¹ Also see "ODAC Calls For Additional EPO Trials To Support Continued Use In Oncology" - Pink Sheet, 10 May, 2007.).

Considering all the available data on benefits and risks associated with ESAs, the panel voted 13-1 to recommend to FDA that the products continue to be marketed.

That "worst case" scenario "was clearly avoided today," Bear Stearns analyst Mark Schoenebaum said in a same-day briefing. However, he projects that "Amgen could see sales fall perhaps 40 percent from the annualized fourth quarter [2007] level," if FDA acts on ODAC's advice.

The panel opted to recommend that the label exclude indications for malignancies in which risks have been observed (breast and head and neck cancers) rather than limit use of the drugs to a cancer subtype that has been shown to be safe (small-cell lung cancer).

A restricted distribution program would be unduly burdensome for the drug makers, the panel said. However, it recommended that doctors have patients sign an informed consent agreement prior to ESA administration.

The sponsors said they submitted data from 18 additional studies to FDA for review, which could prompt future ODAC review of the products that lack significant safety information related to their on-label use.

-Brian Marson (b.marson@elsevier.com)

Amgen’s Aranesp, Procrit CIA Indications Okay For Incurable Cancers - ODAC

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