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  5. Drug Trials Snapshots: REZUROCK
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Drug Trials Snapshots: REZUROCK

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when considering the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.

Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the REZUROCK Prescribing Information for all of the approved conditions of use for this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).

Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).

REZUROCK (belumosudi)
(Rez'-ur-ok )
Kadmon Pharmaceuticals LLC
Approval date: July 16, 2021


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

REZUROCK is a drug used in adults and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior treatments.

Chronic GVHD is a complication that can occur after stem cell or bone marrow transplantation in which the transplanted donor cells attack the transplant recipient’s body.

How is this drug used?

REZUROCK is a 200 mg tablet taken by mouth once daily with food.

Who participated in the clinical trials?

The FDA approved REZUROCK based on evidence from one clinical trial of 65 patients with chronic GVHD to evaluate efficacy of REZUROCK at 200 mg once daily. A total of eighty-three (83) patients were evaluated for safety; therefore, the number of patients representing efficacy findings may differ from the number of patients representing safety findings due to different pools of study participants analyzed for efficacy and safety. The trial was conducted at 28 sites in the United States.

How were the trials designed?

REZUROCK was evaluated in one single-arm clinical trial of 65 patients with chronic GVHD for efficacy. A total of eighty-three (83) patients were evaluated for safety. All patients received 200 mg REZUROCK once daily until chronic GHVD worsens that requires new treatment.

The benefit of REZUROCK was evaluated by measuring how many patients had responded to the treatment and by how long that response lasted.

What are the benefits of this drug?

Seventy-five percent of 65 patients who were treated with REZUROCK experienced complete or partial response. The time from treatment to first response was 1.8 months. The majority of responding patients (62 percent) did not need additional treatment for at least 12 months after response.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: REZUROCK worked similarly in males and females.
  • Race: The number of patients of races other than White was small; therefore, differences in how REZUROCK worked among races could not be determined.
  • Age: The number of patients over 65 years of age was small; therefore, differences in how REZUROCK worked among age groups could not be determined.

What are the possible side effects?

The most common side effects of REZUROCK are infection, tiredness or weakness, nausea, diarrhea, shortness of breath, cough, swelling, bleeding, stomach (abdominal) pain, muscle or bone pain, headache, and high blood pressure.

Based on animal studies, REZUROCK can be harmful to an unborn baby when given to a pregnant woman.

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in males and females.
  • Race: The occurrence of side effects was similar in White and Black or African American patients.
  • Age: The occurrence of side effects was similar in patients below and above 65 years of age.

Demographic Snapshot

Figure 1 summarizes how many males and females were enrolled in the clinical trial used to evaluate the efficacy of REZUROCK.

Figure 1. Baseline Demographics by Sex (Efficacy Population)

Pie chart summarizing how many men and women were in the clinical trial. In total, 42 (65%) men and 23 (35%) women participated in the clinical trial.

Source: REZUROCK Prescribing Information

Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the efficacy of REZUROCK.

Figure 2. Baseline Demographics by Race (Efficacy Population)

Pie chart summarizing how many White, Black,  other patients were in the clinical trial.  In total, 54 (83%) white patients, 6(9%) black patients, and 5(8%),  Other patients participated in the clinical trial.

Source: REZUROCK Prescribing Information

Table 8. Demographics of Efficacy Trial by Race

Race Number of Patients Percentage
White 54 83
Black 6 9
Other or not reported 5 8

Source: REZUROCK Prescribing Information

Figure 3 summarizes how many patients of certain age were enrolled in the clinical trial.

Figure 3. Baseline Demographics by Age (Efficacy Population)

Pie chart summarizing how many patients by age were in the clinical trial. In total, 48 (74%) patients below the age of 65 years of age and 17(26%) patients above the age of 65 years of age participated in the clinical trial.)

Source: REZUROCK Prescribing Information

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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