FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy

Donna Przepiorka,Robert Q Le,Alexei Ionan,Ruo-Jing Li,Ying-Hong Wang,Ramadevi Gudi, Soumya Mitra,Jonathon Vallejo,Olanrewaju O Okusanya,Lian Ma,Yuching Yang,Paresma Patel, Djelila Mezaache, Rakhi Shah,Anamitro Banerjee,Sherita McLamore,Adam N Maung,Kirsten B Goldberg,Richard Pazdur,Marc R Theoret,R Angelo De Claro

CLINICAL CANCER RESEARCH（2022）

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摘要

On July 16, 2021, the FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD (cGvHD) after failure of at least two prior lines of systemic therapy. Approval was based on the results of Study KD025???213, which included 65 patients with cGvHD treated with belumosudil 200 mg daily in an open-label, single-arm cohort. Efficacy was determined by the overall response rate (ORR) through Cycle 7 Day 1, which included complete response (CR) or partial response (PR) according to the 2014 NIH consensus criteria, and durability of response. The ORR through Cycle 7 Day 1 was 75%

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