FDA Accepts for Review Ibrutinib’s sNDA for cGVHD

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.

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.”

References

1. 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.
2. 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 58^th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.