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Drug Trials Snapshots: ELREXFIO

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 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 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 ELREXFIO Prescribing Information for all of the approved conditions of use of 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).

ELREXFIO (elranatamab-bcmm)
el-reks-fe-o
Pfizer, Inc.
Approval date: August 14, 2023


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

ELREXFIO is a drug used to treat a form of blood cancer called multiple myeloma. It is to be used in patients whose cancer came back after, or did not respond to, at least four previous treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

How is this drug used?

ELREXFIO is given by a healthcare provider as an injection under the skin (subcutaneous injection). ELREXFIO is given at lower “step-up” doses during the first week. After the first full “treatment” dose, ELREXFIO is given once every week. Later, it may be given every two weeks.

The healthcare provider will decide how many treatment cycles will be given.

Who participated in the clinical trials?

The FDA approved ELREXFIO based on evidence from a clinical trial (NCT04649359) of 187 patients with relapsed or refractory multiple myeloma. The same trial was used to assess efficacy and safety. Safety findings were analyzed from 183 patients who received ELREXFIO at the recommended dosing regimen. The efficacy of ELREXFIO was based on 97 patients whose cancer came back after, or did not respond to, at least four prior treatment regimens, which included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The trial was conducted at 53 study centers in 10 countries.

How were the trials designed?

ELREXFIO was evaluated in a clinical trial of 187 adult patients with multiple myeloma whose disease came back after, or did not respond to, previous treatments. All patients in the trial received ELREXFIO until the disease progressed or the side effects became too toxic.


DEMOGRAPHICS SNAPSHOT

Figure 1 summarizes the percentage of males and females in the clinical trial used to evaluate the efficacy of ELREXFIO.

Figure 1. Baseline Demographics by Sex (Efficacy Population)

Pie chart summarizing how many male and female patients were in the clinical trial. In total, 58 (60%) male patients and 39 (40%) female patients participated in the clinical trial.

Source: Adapted from FDA Review

Figure 2 summarizes how many patients by race were enrolled in the clinical trial used to evaluate the efficacy of ELREXFIO.

Figure 2. Baseline Demographics by Race, Efficacy Population

Pie chart summarizing how many White, Black or African American, Asian, and other patients were in the clinical trial. In total, 58 (60%) White patients, 5 (5%) Black or African American patients, 13 (13%) Asian patients, and 21 (22%) other patients participated in the clinical trial.

Source: Adapted from FDA Review
* Other includes unknown and not reported race patients

Figure 3 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of ELREXFIO.

Figure 3. Baseline Demographics by Age, Efficacy Population

Pie chart summarizing how many patients by age were in the clinical trial. In total, 32 (33%) patients between 18 and 65 years of age, 47 (48%) patients between 65 and 75 years of age, and 18 (19%) patients 75 years of age or older participated in the clinical trial.

Source: Adapted from FDA Review

Figure 4 summarizes how many patients by ethnicity were enrolled in the clinical trial used to evaluate the efficacy of ELREXFIO.

Figure 4. Baseline Demographics by Ethnicity, Efficacy Population

Pie chart summarizing how many Hispanic, not Hispanic, and other patients were in the clinical trial. In total, 7 (7%) Hispanic or Latino patients, 69 (71%) not Hispanic or Latino patients, and 21 (22%) other patients participated in the clinical trial.

Source: Adapted from FDA Review
* Other includes not reported and missing ethnicity patients

What are the benefits of this drug?

In the trial, 56 of 97 patients treated with ELREXFIO experienced an improvement in their disease. For 90% of patients who responded, that improvement lasted at least six months. For 80% of patients who responded, that improvement lasted for at least nine months.

ELREXFIO was approved under the 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.

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

  • Sex: ELREXFIO worked similarly in males and females.
  • Race: Most patients who received ELREXFIO in this study were White, and the numbers in other race groups were too small to assess whether ELREXFIO worked better or worse in those groups.
  • Age: ELREXFIO worked similarly in patients younger than 65 and 65 to 74 years of age. The number of patients 75 years of age and above was too small to assess whether ELREXFIO worked better or worse in those patients.

What are the possible side effects?

ELREXFIO may cause side effects that are serious, life-threatening, or lead to death, including cytokine release syndrome (CRS) and neurologic problems, including a neurologic problem called immune effector cell-associated neurotoxicity syndrome (ICANS). Because of the CRS and neurologic problems, including ICANS, ELREXFIO is available only through a drug safety program called ELREXFIO Risk Evaluation Mitigation Strategy.

Other serious side effects include infections, decreased white blood cell counts, liver problems, and harm to an unborn baby.

The most common side effects include: CRS; tiredness; injection site reaction, such as redness, itching, pain, bruising, rash, swelling, or tenderness; diarrhea; upper respiratory tract infection; muscle and bone pain; pneumonia; decreased appetite; rash; cough; nausea; and fever. These are not all the possible side effects of ELREXFIO.

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: Most patients who received ELREXFIO in this study were White, and the numbers in other race groups were too small to assess whether there were differences in the occurrence of side effects among race groups.
  • Age: The occurrence of side effects was similar across age groups.

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.
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.
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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