Ariad asks FDA for priority review of leukemia drug
  • Tue, 07/31/2012 - 3:58pm

On Monday, Ariad Pharmaceuticals Inc. asked the FDA for priority review and accelerated approval of its drug ponatinib, a medicine intended for chronic myeloid leukemia patients who have not responded to conventional treatments.

Ariad filed the request a month earlier than anticipated.

“We were able to put the pedal to the metal and get it done ahead of schedule,” said the company’s chief executive, Harvey J. Berger.

Two years ago, the U.S. Food and Drug Administration gave Ariad a “fast-track” designation, a process created to make drug development and review easier and faster. The FDA website states that it only grants “fast-track” classifications to those drugs developed to treat serious illnesses for which no treatment exists or more effective treatment is needed.

Priority review designation applies to drugs that provide significant medical advancement or treat conditions that have no other treatment options, according to the FDA website. If the FDA approves ponatinib for priority review, drug regulators would review the drug in six months opposed to the ten months they spend during the standard review process.

The FDA website says that if ponatinib has a significant clinical outcome (measured by survival or symptom improvement), it could approve the drug faster. Berger says this approval would allow Ariad to distribute ponatinib as early as the first quarter of next year.

Ponatinib, a BCR-ABL inhibitor, hinders the genetic abnormality that leads to chronic myeloid leukemia, The Boston Globe reports. MedicineNet defines chronic myeloid leukemia as an invasive white blood cell cancer.

Ariad Pharmaceuticals aspires to extend ponatinib as a treatment for recently diagnosed patients and has begun a late-stage clinical trial, which contrasts the standard chronic myeloid leukemia treatment to its new drug.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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