Further Restrictions Likely On ESA Use

From The Cancer Letter, March 21, 2008:

Last year, the companies that market erythropoiesis-stimulating agents could still argue before Wall Street analysts that chemotherapy-related anemia was largely undertreated and that the franchise would once again continue to expand.

Now, expansion is no longer an option. As utilization of ESAs continues to decline amid safety concerns, FDA officials are discussing the recommendations they received at the March 13 meeting of the Oncologic Drugs Advisory Committee.

The sponsors will not be in a position of strength as they negotiate label changes, because FDA has been granted the power to act unilaterally and mandate studies in cases where safety issues are involved. The new authorities will become effective on March 25.

Click on "The Cancer Letter Archive" at left to download the March 21 issue and read the rest of the story.
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tags: FDA|  drug development