(By Balachander) Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) said U.S. regulators have approved its drug Iclusig (ponatinib) to treat two rare types of leukemia.
The U.S. Food and Drug Administration (FDA) cleared ponatinib more than three months ahead of schedule, the agency said in a statement.
Ponatinib is being approved to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) -- rare blood and bone marrow diseases.
"Iclusig is the third drug approved to treat CML and the second drug approved to treat ALL this year, demonstrating FDA's commitment to approving safe and effective drugs for patients with rare diseases," the FDA said.
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The agency said Iclusig blocks certain proteins that promote the development of cancerous cells. The drug provides a treatment option to patients with CML who are not responding to other drugs, particularly those with the T315I mutation who have had few therapeutic options.
"The addition of Iclusig to the arsenal of anti-leukemia medicines is a significant development and one that offers hope for patients coping with CML and Philadelphia-positive ALL," said Rosalie Canosa, program division director at CancerCare.
The FDA said the drug's effectiveness was demonstrated by a reduction in the percentage of cells expressing the Philadelphia chromosome genetic mutation found in most CML patients, major cytogenetic response (MCyR).
Iclusig is being approved with a Boxed Warning alerting patients and health care professionals that the drug can cause blood clots and liver toxicity, the FDA said.
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The most common side effects reported during clinical trials include high blood pressure, rash, abdominal pain, fatigue, headache, dry skin, constipation, fever, joint pain, and nausea.
The stock, which has been trading in the 52-week range of $10.64 to $25.40, retreated 14.28 percent to trade at $20.47 on Friday.