ARIAD Pharmaceuticals, Inc., an integrated global oncology company, has temporarily suspended the marketing and commercial distribution of Iclusig (ponatinib), a treatment for patients with resistant or intolerant chronic myeloid leukaemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), in the United States, while it continues to negotiate updates to the US prescribing information for Iclusig and implementation of a risk mitigation strategy.
The company's actions have been taken in response to a request by the US Food and Drug Administration (FDA). ARIAD believes that Iclusig is an important medicine for patients with resistant or intolerant Philadelphia-positive leukaemias and is actively working with the FDA on actions to achieve the resumption of marketing of Iclusig.
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukaemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was designed using ARIAD's computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, a common mutation which has been associated with resistance to other approved TKIs.
ARIAD Pharmaceuticals, Inc., is focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is also working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers.