Ponatinib Approved for CP-CML Not Indicated for Prior TKI

Share this content:
The FDA has approved ponatinib (Iclusig) for the treatment of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia in chronic phase.
The FDA has approved ponatinib (Iclusig) for the treatment of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia in chronic phase.

The U.S. Food and Drug Administration (FDA) has granted full approval to ponatinib (Iclusig) for the treatment of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia in chronic phase (CP-CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for adult patients not indicated for any other tyrosine kinase inhibitor (TKI) therapy, according to a release.1

Manufactured by Ariad Pharmaceuticals, ponatinib was evaluated in the phase 2 PACE (ClinicalTrials.gov Identifier: NCT01207440) trial, which evaluated 4-year follow-up data of 449 patients with CML or Ph+ ALL who were resistant or intolerant to dasatinib or nilotinib.

About 93% of observed patients received at least 2 approved TKIs and 56% received at least 3 approved TKIs prior to treatment.

In total, 55% of the patients had achieved the primary endpoint of major cytogenetic response at any time during the study, while 39% of patients achieved major molecular response at any time.

About one-third of patients (150 of 449) experienced arterial occlusive events with 4 years of follow-up, including 21% with cardiac vascular, 12% with peripheral vascular, and 9% with cerebrovascular arterial occlusive.

RELATED: Fecal Occult Blood Test With Colonoscopy May Detect Colitis Risk Among CML Patients

Ponatinib is also being evaluated for optimal dose through the Optimizing Ponatinib Treatment in CML (OPTIC; ClinicalTrials.gov Identifier: NCT02467270) randomized trial, which is enrolling patients with CP-CML who are resistant to at least 2 approved TKI therapies. Initial data are expected at the American Society of Hematology 2017 meeting.

Reference

  1. ARIAD announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from phase 2 PACE clinical trial. Ariad website. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2226080. Updated November 29, 2016. Accessed November 30, 2016.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs