Announces in conjunction with STA approval of Iclusig (Ponatinib) in Australia
ARIA and Specialised Therapeutics Australia Pty Ltd (STA), today announced the marketing approval of IclusigTM (ponatinib) in Australia by the Therapeutic Goods Administration (TGA).
ARIAD submitted its marketing application for Iclusig in the third quarter of 2013 to the Therapeutics Goods Administration (TGA), in Australia. Commercial launch of Iclusig is expected to occur early in 2015.
The TGA decision was based on results from the pivotal Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial in patients with CML or Ph+ ALL who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, or who had the T315I mutation of BCR-ABL. Iclusig demonstrated anti-leukemic activity achieving a major cytogenetic response (MCyR) in 54 percent of chronic-phase CML patients and in 70 percent of patients with the T315I mutation.1, 2 MCyR within the first 12 months was the primary endpoint of the PACE trial for chronic-phase patients.
In patients with advanced disease, 57% of accelerated-phase CML patients and 34% of blast-phase CML patients achieved a major hematologic response (MaHR) with Iclusig. MaHR within the first 6 months was the primary endpoint in the trial for patients with advanced disease.