(Reuters) - The Food and Drug Administration has agreed to a priority, or six-month, review of Ariad Pharmaceuticals Inc’s experimental leukemia drug ponatinib, the company said on Wednesday.
The deadline for regulatory review of the drug is March 27, 2013. The FDA typically takes 10 months to review drug applications, but grants the shorter period to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
Ariad said earlier this year that a pivotal trial of ponatinib showed that it was effective in more than half of patients who had stopped responding to currently available therapy.
Ariad is seeking U.S. approval for the drug as a treatment for patients with chronic myeloid leukemia who have stopped responding to other drugs and for patients with Philadelphia-chromosome positive acute lymphoblastic leukemia.
Reporting By Deena Beasley; Editing by Bernard Orr