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Iclusig for Chronic Myeloid Leukemia/ Acute Lymphoblastic Leukemia – Details

Project Number pCODR 10056
Brand Name Iclusig
Generic Name Ponatinib
Strength 15 mg and 45 mg tablets
Tumour Type Leukemia
Indication Chronic Myeloid Leukemia/ Acute Lymphoblastic Leukemia
Funding Request For the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is not appropriate, including CML or Ph+ ALL that is T315I mutation positive or where there is prior TKI resistance or intolerance.
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date April 2, 2015
Manufacturer ARIAD Pharmaceuticals, Inc.
Submitter ARIAD Pharmaceuticals, Inc.
Submission Date March 13, 2015
Submission Deemed Complete April 7, 2015
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ March 27, 2015
Check-point meeting May 12, 2015
pERC Meeting July 16, 2015
Initial Recommendation Issued July 30, 2015
Feedback Deadline ‡ August 14, 2015
pERC Reconsideration Meeting September 18, 2015
Clarification Due to the number of items for deliberation, the pERC meeting was conducted over two days. pERC held deliberations for reconsideration items, including ponatinib, on September 18, 2015.
Final Recommendation Issued October 1, 2015
Notification to Implement Issued October 19, 2015

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.