FDA Expands Approval for Ibrutinib To Include Chronic Graft vs Host Disease

Share this content:
The FDA expanded the indications of ibrutinib to include the treatment of adult patients with cGVHD who have failed at least one prior therapy.
The FDA expanded the indications of ibrutinib to include the treatment of adult patients with cGVHD who have failed at least one prior therapy.

The US Food and Drug Administration (FDA) expanded the indications of ibrutinib to include the treatment of adult patients with chronic graft vs host disease (cGVHD) who have failed at least one prior therapy.1

Ibrutinib, a kinase inhibitor, is under accelerated approval status for mantle cell lymphoma, and is already indicated for chronic lymphocytic leukemia, Waldenström's macroglobulinemia, and marginal zone lymphoma.

It is the first FDA-approved agent for cGVHD.

The FDA based its approval on evidence from the PCYC-1129 phase 1b/2 trial (ClinicalTrials.gov Identifier: NCT02195869). Forty-two patients with cGVHD who had failed prior therapies received ibrutinib 420mg once daily. Patients continued any ongoing therapies, which included corticosteroids and other immunosuppressants.

The overall response rate (ORR) was 67%, and 48% of patients had a sustained response of 5 months or longer.

Serious adverse effects (AEs) for ibrutinib include hemorrhage, infections, atrial fibrillation, cytopenias, second primary malignancies, hypertension, and tumor lysis syndrome.

RELATED: Ibrutinib Provides Long-term Benefits for Patients With CLL

Ibrutinib also received priority review, breakthrough therapy, and orphan drug designations from the FDA.

Reference

  1. FDA approves treatment for chronic graft versus host disease [news release]. Silver Spring, MD: US Food and Drug Administration; August 2, 2017. https://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm569710.htm? source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed August 2, 2017.

Related Resources

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

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

Sign Up for Free e-newsletters