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  1. Development & Approval Process (Drugs)

Drug Trials Snapshots; DARZALEX

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.

What are the benefits of this drug (results of trials used to assess efficacy)?

Table 2. Efficacy Results for Trial 1

 N=106
Overall response rate (ORR)
95% CI (%)
31 (29.2%)
(20.8, 38.9)
Stringent complete response (sCR)3 (2.8%)
Complete response (CR)0
Very good partial response (VGPR)10 (9.4%)
Partial response (PR)18 (17.0%)

ORR = sCR+CR+VGPR+PR
CI = confidence interval

In the second trial, Overall response rate was 36% (95% CI: 21.6, 52.0%) with 1 CR and 3 VGPR. The median time to response was 1 month (range: 0.5 to 3.2 months). The median duration of response was not estimable (range: 2.2 to 13.1+ months).

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.

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

The figure below depicts the subgroup analyses for the larger trial done in 106 patients.

Figure 4. Trial 1 Subgroup Analyses on Objective Response Rates based on IRC Assessment; All Treated – 16 mg/kg Group

Figure depicts the subgroup analyses for the larger trial done in 106 patients
IRC=independent review committee
FDA Review

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).

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse events in the two clinical trials.

Table 3. Adverse reactions with incidence ≥10% in patients with multiple myeloma treated with DARZALEX 16 mg/kg

System Organ ClassDARZALEX 16 mg/kg
N=156
Incidence (%)
Adverse ReactionAny GradeGrade 3Grade 4
Infusion reaction a4830
General disorders and administration site conditions
Fatigue3920
Pyrexia2110
Chills1000
Respiratory, thoracic and mediastinal disorders
Cough2100
Nasal congestion1700
Dyspnea1510
Musculoskeletal and connective tissue disorders
Back pain2320
Arthralgia1700
Pain in extremity1510
Musculoskeletal chest pain1210
Infections and infestations
Upper respiratory tract infection2010
Nasopharyngitis1500
Pneumonia b 1160
Gastrointestinal disorders
Nausea2700
Diarrhea1610
Constipation1500
Vomiting1400
Metabolism and nutrition disorders
Decreased appetite1510
Nervous system disorders
Headache1210
Vascular disorders
Hypertension1050

a Infusion reaction includes terms determined by investigators to be related to infusion, see below
bPneumonia also includes the terms streptococcal pneumonia and lobar pneumonia
DARZALEX Prescribing Information

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.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes subgroup analysis of treatment-emergent adverse events for the Safety Population in the clinical trials.

Table 4. Subgroup Analyses on Overview of Treatment-Emergent Adverse Events for the Pooled Population

 NTEAESerious TEAE
Sex
Male8482 (97.6%)24 (28.6%)
Female7272 (100%)26 (36.1%)
Race
White119117 (98.3%)40 (33.6%)
Other3737 (100%)10 (27%)
Age
18 to <65>8686 (100%)26 (30.2%)
65 to 74 years5452 (96.3%)20 (37%)
75 and above1616 (100%)4 (25%)

TEAE-treatment-emergent adverse event
Clinical Trial Data

 

WHO WAS IN THE CLINICAL 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 RacePie chart summarizing the percentage of patients by race enrolled in the 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

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

Figure 3. Baseline Demographics by Age

Clinical Trial Data

Table 1. Demographics of Efficacy Trials by Race

RaceNumber of PatientsPercentage
White11976%
Black or African American1610%
Asian96%
Not Collected128%

Who participated in the trials?

The table below summarizes demographics for patients in the pooled clinical trials.

Table 5. Demographics for the Patients in the Two Pooled Clinical Trials

 Total N=156
Demographic Subgroup 
Sex, n (%) 
  Male84 (54)
  Female72 (46)
Age Group, n (%) 
18- <65>86 (55)
≥65 - <75>54 (35)
=75 years-->   >=75 years16 (10)
Race, n (%) 
  White119 (76)
  Black or African American16 (10)
  Asian9 (5.8)
  Other, unknown, and unreported12 (7.7)
Ethnicity, n (%) 
  Hispanic or Latino10 (6)
  Not Hispanic or Latino135 (87)
  Unknown11 (7)

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.

How were the trials designed?

Trial 1 was an open-label trial evaluating DARZALEX monotherapy in patients with relapsed or refractory multiple myeloma who had received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who were double-refractory to a proteasome inhibitor and an immunomodulatory agent. In 106 patients, DARZALEX 16 mg/kg was administered with pre- and post-infusion medication. Treatment continued until unacceptable toxicity or disease progression.

Trial 2 was an open-label dose escalation trial evaluating DARZALEX monotherapy in patients with relapsed or refractory multiple myeloma who had received at least 2 different cytoreductive therapies. In 42 patients, DARZALEX 16 mg/kg was administered with pre- and post-infusion medication. Treatment continued until unacceptable toxicity or disease progression.

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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