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For US Health Care
Professionals Only

For US Health Care
Professionals Only

 * Full Prescribing Information
 * Patient Website
 * Kadmon ASSIST™
 * CONNECT WITH A REPRESENTATIVE

 * IMPACT OF cGVHD
   * Manifestations of cGVHD
   * Challenges of Progression
 * EFFICACY
   * ROCKstar
     Study Design
   * ROCKstar
     Efficacy Data
 * SAFETY
 * MOA
 * DOSING
 * SUPPORT & RESOURCES
   * Kadmon ASSIST
   * Obtaining REZUROCK
   * HCP Resources
   * Patient Resources
 * Kadmon ASSIST™
 * Patient Website

Full Prescribing
Information CONNECT WITH A REPRESENTATIVE
 * Full Prescribing Information
 * Patient Website
 * Kadmon ASSIST™
 * CONNECT WITH A REPRESENTATIVE

 * IMPACT OF cGVHD
   * Manifestations of cGVHD
   * Challenges of Progression
 * EFFICACY
   * ROCKstar
     Study Design
   * ROCKstar
     Efficacy Data
 * SAFETY
 * MOA
 * DOSING
 * SUPPORT & RESOURCES
   * Kadmon ASSIST
   * Obtaining REZUROCK
   * HCP Resources
   * Patient Resources
 * Kadmon ASSIST™
 * Patient Website


THE ROCKSTAR STUDY



 * Study Design
 * Efficacy


REZUROCK WAS EVALUATED IN THE PIVOTAL ROCKSTAR (KD025-213) STUDY IN A REAL-WORLD
DEMOGRAPHIC OF PATIENTS WITH CGVHD1


THE FDA APPROVAL OF REZUROCK WAS BASED ON THE PIVOTAL ROCKSTAR STUDY.1

THE ROCKSTAR STUDY INCLUDED A BROAD RANGE OF PATIENTS WHO WERE REPRESENTATIVE OF
THE GENERAL CGVHD POPULATION.1

These patients had

 * Early-stage cGVHD as well as late-stage disease1,2
 * Diverse ages (≥12 years)1
 * NIH-defined moderate (27%) or severe (70%) cGVHD2

 * A wide range of organ involvement, including fibrotic manifestations1,2
 * A diverse treatment history2
 * Median of 3 prior lines of systemic therapy (30% had received ruxolitinib and
   33% had received ibrutinib)


STUDY DESIGN FOR ROCKSTAR2

ROCKstar was a pivotal phase 2, open-label, randomized, multicenter study that
evaluated the efficacy and safety of REZUROCK in patients with cGVHD after
receiving 2 to 5 prior lines of systemic therapy.2

Exclusion criteria: Patients were excluded from the study if they had a relapse
of their underlying malignancy, had developed posttransplant lymphoproliferative
disease, were currently receiving ibrutinib2 or had any of the following
laboratory results: platelets were < 50 × 109/L; absolute neutrophil count < 1.5
× 109/L; AST or ALT > 3 × ULN; total bilirubin > 1.5 × ULN; QTc(F) >480 ms; eGFR
<30 mL/min/1.73 m2; or FEV1 ≤39%.1

Screening for eligibility was conducted within 14 days of C1D1.2

Certain concurrent immunosuppressive medications were allowed, as drug-drug
interactions were not anticipated.2

aThe Karnofsky/Lansky Performance Status Scale is used in outcome-based analyses
to determine the functional status of a patient. The Karnofsky Scale is designed
for patients aged ≥16 years, whereas the Lansky Scale is designed for patients
aged ≤16 years. The scale range for both is 10 to 100.3

bThe final FDA interpretation of the ROCKstar study omitted 1 patient from the
REZUROCK 200-mg once-daily arm. As a result, there are minor differences between
the ROCKstar publication, where n=66, and the Prescribing Information, where
n=65.

cORR was defined as the proportion of patients who achieved CR or PR. All
responses were assessed by the study site investigators.1

dPrespecified secondary end points; not powered to show statistical
significance.

eDOR was measured from the time of initial PR or CR until documented progression
from best response of cGVHD, time from initial response to start of additional
systemic cGVHD therapy or death.2

fThe 7-day LSS summary score was calculated based on the developer
recommendations and was compared with the score from baseline in an exploratory
analysis. An improvement of ≥7 points was considered clinically meaningful.2

gFFS was defined as the absence of relapse, nonrelapse mortality or a need for
additional systemic therapy.2

hOS was defined as the time from the first dose of REZUROCK to the date of death
due to any cause.4


SELECT BASELINE CHARACTERISTICS2,4

The baseline demographics demonstrate the diversity of the patient population in
the ROCKstar study. Many patients presented with challenging characteristics,
including advanced or complex disease and having received multiple prior lines
of systemic therapy.

CharacteristicsREZUROCK 200 mg once daily (n=66)b Median age, y (range) 53
(21-77) Male, n (%) 42 (64) Median prior lines of systemic therapy, n 3 Median
time from cGVHD diagnosis to enrollment, mo (range) 25 (2-162) Median
prednisone-equivalent dose at enrollment, mg/kg/d (range) 0.20 (0.03-0.95)
Concomitant PPI use, n (%) 33 (50) ≥4 organs involved, n (%) 33 (50) Previous
aGVHD, n (%) 42 (64) Refractory to prior line of systemic therapy, n (%i) 44
(79) NIH-defined cGVHD severity, n (%) Severe 46 (70) Moderate 18 (27) Mild 2
(3) Prior systemic cGVHD therapy type, n (%) CS (prednisone) 65 (99) Tacrolimus
40 (61) ECP 31 (47) Sirolimus 29 (44) Ibrutinib 22 (33) Ruxolitinib 20 (30)
Cyclosporine 4 (6) Imatinib 3 (5)

bThe final FDA interpretation of the ROCKstar study omitted 1 patient from the
REZUROCK 200-mg once-daily arm. As a result, there are minor differences between
the ROCKstar publication, where n=66, and the Prescribing Information, where
n=65.

iDenominator excludes patients with unknown status.1


MOST PATIENTS IN THE ROCKSTAR STUDY HAD MODERATE OR SEVERE CGVHD BASED ON THE
2014 NIH CGVHD CONSENSUS CRITERIA2




bThe final FDA interpretation of the ROCKstar study omitted 1 patient from the
REZUROCK 200-mg once-daily arm. As a result, there are minor differences between
the ROCKstar publication, where n=66, and the Prescribing Information, where
n=65.


A BROAD RANGE OF ORGAN INVOLVEMENT4

Organ involvementPatients (n=66),b
n (%) Eyes 48 (73) Skin 55 (83) Mouth 30 (46) Joints/Fascia 51 (77) Lungs 24
(36) Upper GI 13 (20) Esophagus 19 (29) Lower GI 6 (9) Liver 9 (14)

bThe final FDA interpretation of the ROCKstar study omitted 1 patient from the
REZUROCK 200-mg once-daily arm. As a result, there are minor differences between
the ROCKstar publication, where n=66, and the Prescribing Information, where
n=65.


EFFICACY WAS ACHIEVED

in a real-world demographic of patients.1

See the results


aGVHD, acute graft-versus-host disease; ALT, alanine aminotransferase; AST,
aspartate aminotransferase; cGVHD, chronic graft-versus-host disease; C1D1,
cycle 1 day 1; CNI, calcineurin inhibitor; CR, complete response; CS,
corticosteroid(s); DOR, duration of response; ECP, extracorporeal photopheresis;
eGFR, estimated glomerular filtration rate; FDA, US Food and Drug
Administration; FEV1, forced expiratory volume in 1 second; FFS, failure-free
survival; GI, gastrointestinal; HCT, hematopoietic cell transplant; LFT, liver
function test; LSS, Lee Symptom Scale; mITT, modified intent-to-treat; MOA,
mechanism of action; NIH, National Institutes of Health; NRM, nonrelapse
mortality; ORR, overall response rate; OS, overall survival; PPI, proton pump
inhibitor; PR, partial response; QOL, quality of life; TTR, time to response;
ULN, upper limit of normal.

References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2.
Cutler C, Lee SJ, Arai S, et al; on behalf of the ROCKstar Study Investigators.
Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of
therapy: the ROCKstar Study. Blood. 2021;138(22):2278-2289.
doi:10.1182/blood.2021012021 3. Center for International Blood and Marrow
Transplant Research. Karnofsky/Lansky performance status. Accessed April 20,
2022.
https://www.cibmtr.org/DataManagement/TrainingReference/Manuals/DataManagement/Documents/appendix-l.pdf
4. Data on file. Kadmon Pharmaceuticals, LLC; 2021.


INDICATION

REZUROCK® (belumosudil) 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.


IMPORTANT SAFETY INFORMATION


WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action,
REZUROCK can cause fetal harm when administered to a pregnant woman. Advise
pregnant women of the potential risk to a fetus. Advise females of reproductive
potential and males with female partners of reproductive potential to use
effective contraception during treatment with REZUROCK and for at least one week
after the last dose


ADVERSE REACTIONS

The most common (≥ 20%) adverse reactions, 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

Permanent discontinuation of REZUROCK due to adverse reactions occurred in 18%
of patients. The adverse reactions which resulted in permanent discontinuation
of REZUROCK in > 3% of patients included nausea (4%). Adverse reactions leading
to dose interruption occurred in 29% of patients. The adverse reactions leading
to dose interruption in ≥ 2% were infections (11%), diarrhea (4%), and asthenia,
dyspnea, hemorrhage, hypotension, liver function test abnormal, nausea, pyrexia,
edema, and renal failure with (2% each)

Monitor total bilirubin, aspartate aminotransferase (AST), and alanine
aminotransferase (ALT) at least monthly


DRUG INTERACTIONS

Strong CYP3A Inducers: Coadministration of REZUROCK with strong CYP3A inducers
decreases belumosudil exposure, which may reduce the efficacy of REZUROCK.
Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with
strong CYP3A inducers

Proton Pump Inhibitors: Coadministration of REZUROCK with proton pump inhibitors
decreases belumosudil exposure, which may reduce the efficacy of REZUROCK.
Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with
proton pump inhibitors


USE IN SPECIFIC POPULATIONS

Pregnancy: Based on findings from animal studies and the mechanism of action,
REZUROCK can cause fetal harm when administered to pregnant women. There are no
available human data on REZUROCK use in pregnant women to evaluate for a
drug-associated risk. Advise pregnant women and females of reproductive
potential of the potential risk to the fetus

Lactation: There are no data available on the presence of belumosudil or its
metabolites in human milk or the effects on the breastfed child, or milk
production. Because of the potential for serious adverse reactions from
belumosudil in the breastfed child, advise lactating women not to breastfeed
during treatment with REZUROCK and for at least one week after the last dose

Pediatric Use: The safety and effectiveness of REZUROCK have been established in
pediatric patients 12 years and older. The safety and effectiveness of REZUROCK
in pediatric patients less than 12 years old have not been established

Geriatric Use: Of the 186 patients with chronic GVHD in clinical studies of
REZUROCK, 26% were 65 years and older. No clinically meaningful differences in
safety or effectiveness of REZUROCK were observed in comparison to younger
patients

Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in
patients with pre-existing severe renal or hepatic impairment. For patients with
pre-existing severe renal or hepatic impairment, consider the risks and
potential benefits before initiating treatment with REZUROCK

Please see full Prescribing Information for additional Important Safety
Information.

You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon
Pharmaceuticals, LLC, at 1-877-377-7862 to report side effects.

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MAT-US-2201624-v1.0-05/2022    
Last updated: May 2022

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INDICATION

REZUROCK® (belumosudil) 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 any two prior lines of systemic therapy.


IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action,
REZUROCK can cause fetal harm when administered to a pregnant woman. Advise
pregnant women of the potential risk to a fetus. Advise females of reproductive
potential and males with female partners of reproductive potential to use
effective contraception during treatment with REZUROCK and for at least one week
after the last dose


IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action,
REZUROCK can cause fetal harm when administered to a pregnant woman. Advise
pregnant women of the potential risk to a fetus. Advise females of reproductive
potential and males with female partners of reproductive potential to use
effective contraception during treatment with REZUROCK and for at least one week
after the last dose