ARIAD Pharmaceuticals announced that following a priority review, the FDA has granted accelerated approval of Iclusig (ponatinib) for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
The FDA approval of Iclusig 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 TKI therapy, or who had the T315I mutation of BCR-ABL. A total of 54% of chronic-phase CML patients, including 70% of patients with the T315I mutation, achieved a major cytogenetic response (MCyR) – the primary endpoint of the PACE trial for chronic-phase patients. In patients with advanced disease, 52% of accelerated-phase CML patients, 31% of blast-phase CML patients and 41% of Ph+ ALL patients achieved a major hematologic response (MaHR) to Iclusig. MaHR was the primary endpoint in the trial for patients with advanced disease.
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL.
Iclusig will be available as 15mg and 45mg tablets within approximately two weeks through a number of select specialty pharmacies. ARIAD has established the ARIAD PASS (Patient Access and Support Services) program, a comprehensive support system designed to help patients access, afford and adhere to treatment with Iclusig, including patients without insurance or who are underinsured. The program also includes ARIAD PASS Nurses who provide treatment support for patients taking Iclusig.
For more information call (877) 621-2302 or visit www.iclusig.com.