Ponatinib is indicated for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Ariad chairman and CEO Harvey Berger said the company is ahead of schedule in the submission of our NDA to the FDA and have taken advantage of the rolling submission process, at the Agency’s request, to submit essentially a complete file early in the third quarter.
"If approved, we believe that ponatinib will become an important new medicine for CML and Ph+ ALL patients who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy, " Berger added.
Ariad is expecting the approval and commercial launch of ponatinib in the US in the first quarter of 2013.
The company is also planning to submit a marketing authorization application (MAA) for ponatinib to the European Medicines Agency (EMA) this quarter.