FDA Accepts for Review Ibrutinib's sNDA for cGVHD
The FDA accepted for review a supplemental New Drug Application for ibrutinib as a treatment for chronic graft-versus-host-disease.
The US Food and Drug Administration (FDA) will review a supplemental New Drug Application (sNDA) for ibrutinib as a treatment of chronic graft-versus-host-disease (cGVHD) after the failure of steroid therapy, according to a press release.1
cGHVD is a potentially fatal condition that can arise after allogeneic stem cell transplant. It occurs in about 30% to 70% of patients, and is usually treated with a corticosteroid. There has, however, been a lack of FDA-approved alternatives if steroid-therapy fails.
Ibrutinib, a Bruton's kinase inhibitor, was evaluated as a second-line therapy for patients with cGVHD in a phase 1b/2 trial (ClinicalTrials.gov Identifier: NCT02195869), from which data were presented at the 2016 American Society of Hematology Annual Meeting.2
The overall response rate in this study was 67%, with a complete response rate of 21%.
In an ongoing, placebo-controlled, phase 3 trial (ClinicalTrials.gov Identifier: NCT02959944), researchers are evaluating the efficacy and safety of ibrutinib and prednisone as a combination first-line therapy.
RELATED: Ibrutinib for the Relief of GVHD-related Symptoms
Common adverse events among patients with B cell malignancies treated with ibrutinib include “neutropenia, thrombocytopenia, diarrhea, anemia, musculoskeletal pain, rash, nausea, bruising, fatigue, hemorrhage, and pyrexia.”
- U.S. FDA accepts for review the application of ibrutinib (IMBRUVICA®) for chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy [news release]. Raritan, NJ: Janssen; April 4, 2017. http://www.prnewswire.com/news-releases/us-fda-accepts-for-review-the-application-of-ibrutinib-imbruvica-for-chronic-graft-versus-host-disease-cgvhd-after-failure-of-one-or-more-lines-of-systemic-therapy-300434062.html?tc=eml_cleartime. Accessed April 4, 2017.
- Miklos D, Cutler CS, Arora M, et al. Multicenter open-label phase 2 study of ibrutinib in chronic graft versus host disease (cGVHD) after failure of corticosteroids. Paper presented at: American Society of Hematology 58th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.