tment option for leukemia patients.”
“For patients with CML and Philadelphia-positive ALL who become resistant or intolerant to TKI treatments, the approval of Iclusig is very positive news,” said Rosalie Canosa, program division director at CancerCare. “The addition of Iclusig to the arsenal of anti-leukemia medicines is a significant development and one that offers hope for patients coping with CML and Philadelphia-positive ALL.”
The FDA approval of Iclusig was based on results from the pivotal Phase 2 PACE (Ponatinib Ph+ ALL and CML eva luation) 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. Iclusig had robust anti-leukemic activity, with 54 percent of chronic-phase CML patients, including 70 percent of patients with the T315I mutation, achieving a major cytogenetic response (MCyR) – the primary endpoint of the PACE trial for chronic-phase patients.
In patients with advanced disease, 52 percent of accelerated-phase CML patients, 31 percent of blast-phase CML patients and 41 percent 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.
ARIAD PASS™ Patient Access and Support Services
Iclusig will be available to patients in the United States within approximately two weeks through a number of select specialty pharmacies. The Company 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. ARIAD PASS offers coverage support, including benefits verification and financial assistance through dedicated benefits coordinators. The program also includes ARIAD PASS Nurses who provide treatment support for patients taking Iclusig.
Healthcare professionals or patients can access information about ARIAD PASS by calling 1-855-447-PASS (855-447-7277) or visiting www.ARIADPASS.com.
Today’s Conference Call
ARIAD will hold a conference call and webcast today, December 14, at 1:30 p.m. ET to discuss the FDA approval of Iclusig, its availability, reimbursement and patient assistance program. The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 866-831-5605 (domestic) or 617-213-8851 (international) five minutes prior to the start time and providing the pass code 51636171. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.
About Iclusig (ponatinib)
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which is the most common mutation among resistant patients. Iclusig is the only TKI that is effective in CML and Ph+ ALL pa |
