Is Epcoritamab approved by the FDA?

Yes, epcoritamab, marketed under the brand name Epkinly, is FDA approved. It received approval on May 19, 2023.

What is Epcoritamab?

Epcoritamab is a medication used to treat certain types of lymphoma, specifically for adults whose cancer has returned or did not respond to previous treatments. Patients eligible for epcoritamab treatment must have undergone at least two prior cancer therapies. Epcoritamab belongs to the drug class known as CD20 monoclonal antibodies and is administered as a subcutaneous solution.

Usage and Dosage

• Dosage Form: Subcutaneous solution (bysp 4 mg/0.8 mL; bysp 48 mg/0.8 mL)
• Administration:
  • Epcoritamab is given as an injection under the skin, usually in the lower part of the stomach area or thigh.
  • A healthcare provider administers the injections, and the number of treatment cycles will be determined by the doctor.
  • Other medications may be prescribed to reduce the risk of cytokine release syndrome (CRS), a potential side effect.
  • Regular medical tests will be required during treatment to monitor for CRS and other side effects.

Side Effects

Common side effects of epcoritamab may include:

• Tiredness
• Bone and muscle pain
• Stomach pain
• Fever
• Nausea, diarrhea
• Bruising, swelling, warmth, redness, oozing, or bleeding at the injection site

Serious side effects that require immediate medical attention include:

• Signs of an allergic reaction: hives, difficult breathing, swelling of the face, lips, tongue, or throat
• Symptoms of cytokine release syndrome: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired
• Signs of nervous system disorders: confusion, disorientation, muscle weakness, memory problems, tremors, trouble speaking or writing, tiredness, sleepiness, or seizures
• Low blood cell counts: fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath
• Signs of infection: fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding

Warnings and Precautions

• Medical History: Inform your healthcare provider of any infections or other medical conditions.
• Pregnancy and Breastfeeding:
  • A negative pregnancy test may be required before starting treatment.
  • Epcoritamab may harm an unborn baby. Effective birth control should be used during treatment and for at least four months after the last dose. Inform your doctor if you become pregnant.
  • Avoid breastfeeding during treatment and for at least four months after the last dose.

Treatment Considerations

• Missed Dose: Contact your doctor for instructions if you miss an appointment for your epcoritamab injection.
• Overdose: In a medical setting, an overdose would be treated quickly.
• Activity Restrictions: Avoid driving or engaging in hazardous activities until you know how epcoritamab affects you, as it may impair reactions.

Drug Interactions

• Interactions: Inform your doctor about all other medications you are using, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can interact with epcoritamab, affecting its efficacy or increasing side effects.

Conclusion

Epcoritamab (Epkinly) is an FDA-approved treatment for certain types of lymphoma in adults, with the approval granted on May 19, 2023. It offers a targeted approach for patients who have not responded to previous treatments, although it comes with potential side effects and precautions that must be managed under the supervision of a healthcare provider. Always follow your doctor’s instructions and report any adverse effects promptly during your treatment.

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