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Clinical trials for a leukemia drug have been halted due to a risk of thrombotic events, also known as blood clots.
The U.S. Food and Drug Administration (FDA) has raised some concern over the high rate of thrombotic events in patients being treated with ponatinib (Iclusig), used in the treatment of chronic myeloid leukemia.
Nearly 12 percent of patients treated with ponatinib developed serious arterial thrombotic events during a median follow-up of 24 months. This represents a 50 percent increase compared to results after 11 months of follow-up.
Ariad Pharmaceuticals, the drug's manufacturer, said in a statement:
Patient enrollment in all clinical studies of Iclusig is being paused, and subject to agreement with the FDA, will be resumed with anticipated changes in dose and other modifications. In concert with this action, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig.
This won't affect people who are already receiving the drug, but the dosage will be reduced from 45 mg/d to 30 mg/d (the sole exception being in those patients who have achieved MMR, or a major molecular response). The company will also alter the enrollment criteria to exclude patients with thombotic histories.
Iclusig continues to be available in the U.S. to patients with resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the commercial setting at the approved, once-daily dose of 45 mg.
Source: MedPage Today