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Drug Trial Snapshots: MONJUVI

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.

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 MONJUVI Prescribing Information for complete information.

MONJUVI (tafasitamab-cxix)
MorphoSys US Inc.
Approval date: July 31, 2020


What is the drug for?

MONJUVI is used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose disease has come back or has not improved after previous treatments. It is to be used when patients cannot receive a stem cell transplant.

DLBCL is a fast-growing cancer of the lymph system, which is part of the body’s immune system.

How is this drug used?

MONJUVI is given by a healthcare provider directly into the bloodstream through a needle in the vein. This is known as an intravenous, or IV infusion. MONJUVI is given according to a specific cycle schedule and together with lenalidomide (a type of chemotherapy).

What are the benefits of this drug?

In a clinical trial, of 71 patients with DLBCL assigned to get MONJUVI plus lenalidomide, 55% had complete or partial shrinkage of their tumors that lasted about 22 months.

MONJUVI was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

There are ongoing clinical trials to confirm the clinical benefit of MONJUVI.

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

The trial that looked at the benefit of MONJUVI was too small to determine if there were any differences in sex, race and age subgroups.

What are the possible side effects?

MONJUVI may cause serious side effects including infusion related reactions, bone marrow suppression, infections, and harm to an unborn baby.

The most common side effects of MONJUVI are low blood cell counts, fatigue, diarrhea, cough, fever, limb swelling, upper respiratory infection, and decreased appetite.

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

The trial that looked at the side effects of MONJUVI was too small to determine differences in sex, race and age subgroups.


Who participated in the clinical trials?

The FDA approved MONJUVI based primarily on evidence from one clinical trial (NCT02399085) of 81 patients 42 to 86 years old. Patients who participated in the trial had lymphoma that came back or did not improved after prior treatments. The trial was conducted at 35 sites in the United States and Europe.

Presented below is the trial population that provided data to assess the side effects of MONJUVI (called the safety population).

Figure 1 summarizes how many men and women participated in the trial.

Figure 1. Demographics by Sex (Safety Population)

Pie chart summarizing how many men and women were in the clinical trial. In total, 37 women (46%) and 44 men (54%) participated in the clinical trial.

FDA Review

Figure 2. summarizes trial patients by race.

Figure 2. Demographics by Race (Safety Population)

Pie chart summarizing the percentage of patients by race enrolled in the clinical trial. In total, 27 White (89%), 2 Asian (3%) and 1 Other (1%)

FDA Review

Figure 3 summarizes patients who participated in the trial by age.

Figure 3. Demographics by Age (Safety Population)

Pie charts summarizing how many individuals of certain age groups were enrolled in the clinical trial. In total,  25 (31%) were less than 65 and 56 patients were 65 years and older (69%).

FDA Review

Figure 4 summarizes patients who participated in the trial by ethnicity.

Figure 4. Demographics by Ethnicity (Safety Population)

Pie charts summarizing ethnicity of patients enrolled in the clinical trial. This information was not collected.

FDA Review

How were the trials designed?

There was one trial that evaluated the benefit and side effects of MONJUVI in patients with lymphoma whose disease had returned or had not improved after previous treatment.

At first, patients received MONJUVI in combination with lenalidomide and later MONJUVI alone following a specific schedule during each 28-day treatment cycle. Treatment continued until disease progression or unacceptable side effects. Both patients and health care providers knew which treatment had been given.

The benefit of MONJUVI was evaluated by measuring how many patients had a complete or partial tumor shrinkage and how long that response lasted (called best overall response rate).


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.


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