Belumosudil

1 INDICATIONS AND USAGE REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

REZUROCK is a kinase inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. ( 1 )

REZUROCK is indicated for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable or have been exhausted.

Rezurock is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease (chronic GVHD) who have received at least two prior lines of systemic therapy.

REZUROCK is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. Efficacy in patients with chronic GVHD was based on objective response rate and duration of response in a single-arm study (see 14 CLINICAL TRIALS).

1 Pediatrics Pediatrics (≥ 12-18 years of age): No patients under the age of 18 were enrolled in the clinical development program. Use of REZUROCK in pediatric patients 12 years and older is supported by evidence from studies in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the pharmacokinetics of drug substance, that the exposure of drug substance is expected to be similar between adults and pediatric patients age 12 years and older, and that the course of disease is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to these pediatric patients.