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  5. Drug Trials Snapshots: DARZALEX
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Drug Trials Snapshots: DARZALEX

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age 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 discussing 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 health provider about the risks and benefits of a drug. Refer to the DARZALEX Prescribing Information

DARZALEX (daratumumab)
(Dar'-zah-lex)
Jannsen Biotech
Approval date: November 16, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

DARZALEX is a drug used to treat patients with a form of blood cancer called multiple myeloma. It is for patients who have received at least three prior treatments for their cancer.

How is this drug used?

DARZALEX is given by a healthcare provider as an infusion into a vein. It is given according to a specific schedule.

What are the benefits of this drug?

In two trials, DARZALEX reduced the number of cancer cells or the amount of cancer in the body, also called tumor burden. In one trial, 29% of patients had a partial or complete reduction in their tumor burden, which lasted for an average of 7.4 months. In the second trial, 36% of patients had a partial or complete reduction in their tumor burden.

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

Subgroup analyses were conducted for sex, race and age.

  • Sex: DARZALEX was similarly effective in men and women.
  • Race: Most patients in the trials were white. Differences in response to DARZALEX among races could not be determined.
  • Age: DARZALEX was similarly effective in patients below and above 65 years of age.

What are the possible side effects?

The most common side effects of DARZALEX were reactions related to the infusion of the drug, fatigue, nausea, back pain, fever and cough. DARZALEX may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia) and low levels of blood platelets (thrombocytopenia).

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

Subgroup analyses were conducted for sex, race and age.

  • Sex: The risk of side effects was similar in men and women.
  • Race: Most patients in the trials were white. Differences in side effects among races could not be determined.
  • Age: The risk of side effects was similar in patients below and above 65 years of age.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved DARZALEX based primarily on evidence from 2 clinical trials in 156 patients with multiple myeloma who had received prior treatments. The trials were done in the United States, Canada, Europe, and Japan.

Figure 1 summarizes how many men and women were enrolled in the clinical trials.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were enrolled in the clinical trial used to evaluate efficacy of the drug DARZALEX.  In total, 84 men (54%) and 72 women (46%) participated in the clinical trial used to evaluate efficacy of the drug DARZALEX.

Clinical Trial Data

Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trials.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the DARZALEX clinical trial. In total, 119 Whites (76%), 16 Black or African Americans (10%), 9 Asians (6%), and 12 not collected (8%) participated in the clinical trial.

Clinical Trial Data

Table 1. Demographics of Efficacy Trials by Race

Race Number of Patients Percentage
White 119 76%
Black or African American 16 10%
Asian 9 6%
Not Collected 12 8%

Clinical Trial Data

The Figure below summarizes the perentage of patients by age in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the DARZALEX clinical trial.  In total, 86 participants were below 65 years old (55%) and 70 participants were 65 and older (45%).

Clinical Trial Data

How were the trials designed?

Two trials were conducted in which all patients received DARZALEX. Treatment was continued until there were unacceptable side effects or the cancer progressed.

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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