You are here

Ariad Announces Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration

'Results from the ongoing Phase 2 PACE trial of ponatinib reported in June at this year’s annual meeting of the American Society of Clinical Oncology showed that 54 percent of chronic-phase CML patients who were resistant or intolerant to tyrosine kinase inhibitor therapy in the trial, including 70 percent of patients who have a T315I mutation, achieved a major cytogenetic response (MCyR) – the primary endpoint of the PACE trial. Thirty percent of these same patients achieved a major molecular response (MMR). MMR is the primary endpoint of ARIAD’s Phase 3 EPIC trial comparing ponatinib to imatinib that is now underway in newly diagnosed chronic-phase CML patients.

Thirty percent of these same patients achieved a major molecular response (MMR). MMR is the primary endpoint of ARIAD’s Phase 3 EPIC trial comparing ponatinib to imatinib that is now underway in newly diagnosed chronic-phase CML patients.

ARIAD’s diagnostic collaborator, MolecularMD Corp., also submitted today a Premarket Approval (PMA) application to the FDA to support commercialization of a companion diagnostic test to identify those CML and Ph+ ALL patients who have the T315I mutation of BCR-ABL.

ARIAD also plans to submit, on schedule, a marketing authorization application (MAA) for ponatinib to the European Medicines Agency (EMA) this quarter'

read full press release here:

http://phx.corporate-ir.net/phoenix.zhtml?c=118422&p=irol-newsArticle&ID...