Cambridge-based Ariad Pharmaceuticals said Wednesday that patient enrollment in all clinical studies of its leukemia drug Iclusig is being paused while it reviews more data about the drug’s side effects with the Food and Drug Administration.
Ariad shares were down $11.54 to $5.59 a share as of 9:37 a.m. Wednesday.
Iclusig was approved in by the FDA in December as a third-line treatment for chronic myeloid leukemia, and the drug remains on the market. That approval required the drug to have a so-called black-box label, which warns doctors of potential side effects. Ariad said Wednesday that it has been in consultation with the FDA and other health authorities about changes in Iclusig product labeling.
Under the current FDA approval, Iclusig is generally prescribed for patients who have not benefitted from drugs that were tried earlier. Ariad is continuing to do clinical studies of Iclusig in hopes that the FDA might approve it as a first-line or second line treatment for chronic myeloid leukemia and for use in treating other cancers as well.
Ariad said Wednesday that for the moment, no new patients will be enrolled in its clinical studies of Iclusig. Patients who are currently receiving Iclusig in clinical trials will continue on therapy, the company said in a press release.
“At this time, the US prescribing information for Iclusig is unchanged,” the release said. “Iclusig continues to be available in the US 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. Ariad has been in consultation with the FDA and other health authorities about changes in Iclusig product labeling to reflect the updated information.”
The release included a statement from Harvey J. Berger, MD, Ariad’s chairman and chief executive.
“We believe that the actions we are taking will help us ensure the most appropriate and safe use of Iclusig,” Berger said. “With two years of follow up, we have learned a great deal about both the efficacy and safety of Iclusig in patients with Philadelphia-positive leukemias. “We are focused first and foremost on the needs of cancer patients – to have new medicines that provide both safe and effective treatment of their malignancies. Our unwavering commitment to patients has led us to promptly take the steps we have outlined.”
Iclusig has also been approved for use in Europe.
Ariad management has scheduled a conference call with investors for Wednesday morning.