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FDA Approves Mylotarg for Older Leukemia Patients

Wed, 05/24/2000 - 12:00am — Karen Stevenson
Description: 

American Home Products Corporation received U.S. Food and Drug Administration approval for Mylotarg, under accelerated approval provisions. Mylotarg is intended for the treatment of patients 60 years and older in first relapse with CD33-positive acute myeloid leukemia (AML) who are not considered candidates for cytotoxic chemotherapy.

Acute myeloid leukemia strikes over 9,000 Americans a year, most over age 60. Most eventually relapse, but standard treatment for this type of leukemia causes so many serious side effects in older patients who relapse, and is so much less effective in them, that many doctors do not offer it.

FDA oncology chief Dr. Richard Pazdur said that the hope is that Mylotarg will offer these elderly patients a viable option, but he cautioned that the drug's effects are not yet proved. The FDA approved Mylotarg under a special rule that lets promising drugs for certain lifethreatening diseases to sell before studies prove just how well they work.

Mylotarg was designated an orphan drug in November 1999.

American Home Products Corporation received U.S. Food and Drug Administration approval for Mylotarg, under accelerated approval provisions. Mylotarg is intended for the treatment of patients 60 years and older in first relapse with CD33-positive acute myeloid leukemia (AML) who are not considered candidates for cytotoxic chemotherapy.

Acute myeloid leukemia strikes over 9,000 Americans a year, most over age 60. Most eventually relapse, but standard treatment for this type of leukemia causes so many serious side effects in older patients who relapse, and is so much less effective in them, that many doctors do not offer it.

FDA oncology chief Dr. Richard Pazdur said that the hope is that Mylotarg will offer these elderly patients a viable option, but he cautioned that the drug's effects are not yet proved. The FDA approved Mylotarg under a special rule that lets promising drugs for certain lifethreatening diseases to sell before studies prove just how well they work.

Mylotarg was designated an orphan drug in November 1999.