FDA D.I.S.C.O. Burst Edition: FDA approval of Rezurok (belumosudil) for adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we have a quick update on another recent FDA cancer drug approval.
On July 16, 2021, FDA approved belumosudil (brand name Rezurock), a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.
Efficacy was evaluated in, a randomized, open-label, multicenter dose-ranging trial that included 65 patients with chronic graft-versus-host disease who were treated with belumosudil.
The main efficacy outcome measure was overall response rate through Cycle 7 Day 1 where overall response included complete response or partial response according to the 2014 criteria of the NIH Consensus Development Project on Clinical Trials in Chronic Graft-versus-Host Disease. The overall response rate was 75%; 6% of patients achieved a complete response, and 69% achieved a partial response. The median time to first response was 1.8 months. The median duration of response, calculated from first response to progression, death, or new systemic therapies for chronic graft-versus-host disease, was 1.9 months. In patients who achieved response, no death or new systemic therapy initiation occurred in 62% of patients for at least 12 months since response.
The most common adverse reactions with an incidence of greater than 20%, including laboratory abnormalities, were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners.
This review used the Real-Time Oncology Review pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 6 weeks ahead of the FDA goal date.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatfda.
Healthcare professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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