Results with EPKINLY

How was EPKINLY studied?

EPKINLY was studied in 148 patients with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma who had 2 or more treatments and whose cancer returned or did not respond. Patients had been through a median of 3 different types of treatments (range of prior treatments was 2 to 11), such as chemotherapy, immunotherapy, stem cell transplant, and CAR T therapy. The median is the number that is exactly in the middle of range seen in the study.

CAR T=chimeric antigen receptor T cell.

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EPKINLY makes remission possible

One of the goals of treatment is to achieve a response. A response to treatment means patients either achieved complete remission (disappearance of all signs and symptoms of cancer; this does not mean cure) or partial remission (some measurable decrease in the signs of cancer).


EPKINLY helped 61% of patients achieve a response (complete or partial remission)


EPKINLY helped 38% of patients achieve complete remission

23% of patients achieved a partial remission

Patients started seeing results with a median of ~6 weeks on treatment with EPKINLY™.

In those who responded, the results were seen in a median of ~6 weeks (1.4 months).*

*Range 1 to 8.4 months.

Understanding the possible side effects of EPKINLY

Before deciding on any medication, it’s important to understand its benefits and risks. Here are some important things to keep in mind before taking EPKINLY. If you have any concerns or questions, be sure to talk to your healthcare provider to learn more.

EPKINLY can cause serious side effects, including:

  • Cytokine Release Syndrome (CRS): CRS is common during treatment with EPKINLY and can also be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher, dizziness or light-headedness, trouble breathing, chills, fast heartbeat, feeling anxious, headache, confusion, shaking (tremors), problems with balance and movement, such as trouble walking
  • Neurologic problems: EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including: trouble speaking or writing, confusion and disorientation, drowsiness, tiredness or lack of energy, muscle weakness, shaking (tremors), seizures, memory loss
  • Infections: EPKINLY can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment with EPKINLY. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with EPKINLY, including: fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, and feeling weak or generally unwell
  • Low blood cell counts: Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment with EPKINLY. EPKINLY may cause the following low blood cell counts: including low white blood cell counts (neutropenia), which can increase your risk for infection; low red blood cell counts (anemia), which can cause tiredness and shortness of breath; and low platelet counts (thrombocytopenia), which can cause bruising or bleeding problems.

The most common side effects of EPKINLY include tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea.

Before receiving EPKINLY, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection.
  • are pregnant or plan to become pregnant. EPKINLY may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY.
  • are breastfeeding or plan to breastfeed. It is not known if EPKINLY passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of EPKINLY.

Some people taking EPKINLY experienced cytokine release syndrome (CRS)

When T cells become engaged, they release small proteins called cytokines into the blood to influence and shape the immune response.

CRS is the result of a large, fast release of cytokines that can overwhelm the body. Signs and symptoms include fever of 100.4°F (38°C) or higher, low blood pressure, chills, fast heartbeat, difficulty breathing/low blood oxygen levels, headache, confusion, dizziness or lightheadedness, or loss of balance or trouble walking. Your doctor may recommend treatments to help your body regulate the cytokine response, so please call your healthcare team right away if you have a fever of 100.4° F or higher, as this may be a sign of CRS. Fever may occur within 2 days of starting EPKINLY and should resolve within 2 days.

Some people taking EPKINLY experienced neurological problems

Effects on your nervous system can occur days or weeks after you receive the injection and may initially be subtle. Some of these symptoms may be signs of a serious immune reaction called ICANS (immune effector cell-associated neurotoxicity syndrome). ICANS was seen in 6% of people receiving EPKINLY in the clinical study.

Symptoms of neurological problems include:

  • Confusion and disorientation
  • Memory loss
  • Trouble speaking or writing
  • Drowsiness
  • Tremors
  • Seizure
  • Muscle weakness
  • Tiredness
  • Low amount of energy

What are the most common side effects of EPKINLY?

  • Cytokine release syndrome (CRS)
  • Injection site reactions
  • Feeling tired or weak
  • Joint and muscle pain
  • Fever
  • Abdominal pain
  • Nausea
  • Diarrhea
  • Low blood cell counts (white blood cells, red blood cells, and platelets)

EPKINLY can cause serious side effects. See below.

These are not all the possible side effects of EPKINLY. Talk to your healthcare provider about any concerns or for more information on possible side effects. Call your healthcare provider right away if you experience any side effects. You may report side effects to FDA at 1-800-FDA-1088.


Use this guide to make the most of your appointment with your healthcare provider to discuss if EPKINLY could be right for you.

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Find out how treatment with EPKINLY works and if it may be right for you.