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Ariad's Leukemia Drug Iclusig Gets FDA Nod - Update

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12/14/2012 2:13 PM ET

Ariad Pharmaceuticals Inc. (ARIA: Quote) said Friday the U.S. Food and Drug Administration has granted accelerated approval of Iclusig to treat adult patients with two types of leukemias that are resistant to a prior therapy.

Nevertheless, the drug was found to have serious adverse events including cardiovascular, cerebrovascular, and peripheral vascular thrombosis, with fatalities related to heart and liver problems.

Investors were not too impressed with the news, sending Ariad shares down by 8 percent in late noon trade on the Nasdaq.

The FDA approved Iclusig on a priority basis to treat adults with chronic, accelerated or blast phase chronic myeloid leukemia, or CML, that is intolerant to prior tyrosine kinase inhibitor therapy, or TKI. The drug is also approved to treat Philadelphia chromosome-positive acute lymphoblastic leukemia, or Ph+ ALL, that is resistant to prior TKI therapy.

Ariad said that Iclusig, a once-daily drug, will be available to patients in the U.S. within about two weeks through a number of select specialty pharmacies.

The drug's indication is based upon response rate and there are no trials verifying an improvement in disease-related symptoms or increased survival.

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL. About 5,000 new cases of CML are diagnosed each year in the U.S.

The FDA approval of Iclusig was based on a study which showed Iclusig had robust anti-leukemic activity, with 54 percent of chronic-phase CML patients achieving a major cytogenetic response. In patients with advanced disease, 52 percent of accelerated-phase CML patients, 31 percent of blast-phase CML patients and 41 percent of Ph+ ALL patients achieved a major hematologic response to Iclusig.

But the drug also showed serious adverse events including cardiovascular, cerebrovascular, and peripheral vascular thrombosis.

Twenty patients, or four percent, treated with Iclusig experienced serious congestive heart failure or left ventricular dysfunction, with 4 fatalities, while two percent of patients experienced treatment-emergent hypertension. Hepatotoxicity, including two cases of fatal liver failure in patients with advanced disease, has been observed.

The most common non-hematologic adverse reactions were hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, and nausea, and pyrexia.

Ariad is trading at $21.76, down $2.12 or 8.88%, on a volume of 4 million shares on the Nasdaq.

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by RTT Staff Writer

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