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FDA grants priority review for ponatinib
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The FDA granted a priority review for Ariad Pharmaceutical Inc.’s leukemia drug, ponatinib, the company announced.
Ponatinib is an investigational BCR-ABL inhibitor intended for patients with chronic myeloid leukemia or Philadelphia-chromosome positive acute lymphoblastic leukemia.
Ponatinib targets native BCR-ABL, as well as its isoforms that carry mutations and confer resistance to treatment with existing tyrosine kinase inhibitors, according to an Ariad press release.
Preclinical studies have shown the drug also selectively inhibits certain other tyrosine kinases, including FLT3, RET, KIT, and members of the FGFR and PDGFR families of kinases, according to the press release.
The FDA grants priority review to investigational medicines that it determines have the potential to provide significant improvement in treatment, prevention or diagnosis of a disease.
The agency tries to complete priority reviews within 6 months. The typical review process can take 10 months.
The FDA is expected to make its decision on ponatinib by March 27.