The drug Iclusig (ponatinib) has been approved by the Food and Drug Administration (FDA) to treat two rare types of leukemia, but regulators are requiring that the drug’s label include a black box warning for potentially serious side effects – blood clots and liver toxicity.
Iclusig, made by Ariad Pharmaceuticals Inc., was approved for treatment-resistant chronic myeloid leukemia and for patients with acute lymphoblastic leukemia with a type of chromosome abnormality.
Experts say that the boxed warnings should not have a harsh effect on the sales of the drug because physicians treating patients with these conditions are familiar with the adverse effects caused by the disease and prior treatment. Prescribing doctors would weigh the potential risks against the potential benefits of the drug.
The FDA had initially planned to deliver a decision on Iclusig in late March, but opted to approve the drug much sooner. The drug is currently being reviewed by European drug regulators and a decision is expected in the third quarter of 2013.
Iclusig is Ariad’s first drug to win approval. It is also being tested as a primary treatment for chronic myeloid leukemia and acute myeloid leukemia. About 5,000 people are diagnosed with chronic myeloid leukemia each year.
Ariad is also conducting studies on the drug as a possible treatment for solid tumors.