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Leukemia



FDA Panel Verdict Mixed on Cancer Drug



March 31st, 2000

A divided U.S. federal advisory panel rejected American Home Products' bid to sell Mylotarg to all patients with an aggressive type of leukemia, but said the drug may be useful for elderly patients.

The panel said Mylotarg, being developed with British firm Celltech Group Plc, appeared safe and effective for patients over age 60 with relapsed acute myeloid leukemia (AML). By a vote of 11-2, members urged the U.S. Food and Drug Administration to consider approving Mylotarg only for elderly patients, who have virtually no other options once their disease returns. However, opponents said the company's studies on Mylotarg did not clearly show the drug worked as well as...


Source: Drug Week (2000-03-31)

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