Powerful results: EPKINLY helps you achieve and sustain remission

EPKINLY for the treatment of DLBCL is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY.

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In the clinical study:

Overall response

61% (90 of 148 patients)

achieved complete or partial remission (signs of cancer either disappeared or decreased)

38%

(56 of 148 patients)

achieved complete remission (signs of cancer disappeared completely)

23%

(34 of 148 patients)

achieved partial remission (signs of cancer decreased)

15.6 MONTHS

Of the 90 patients who achieved complete or partial remission, half were estimated to still respond to EPKINLY for at least 15.6 months

Remission achieved in less than 2 months

Approximately 4 weeks.

Some patients achieved results in as few as 4 weeks
(median* of 1.4 months; time varied from 1 to 8.4 months)

*The median is the number that is exactly in the middle of range seen in the study.

How was EPKINLY studied?

EPKINLY was studied in 148 patients with DLBCL who had 2 or more treatments and whose cancer returned or did not respond.

Half of the patients had tried at least 3 other treatments (number of treatments tried varied from 2 to 11), such as chemotherapy, immunotherapy (uses your body's immune system to help fight cancer), stem cell transplant, and CAR T therapy (chimeric antigen receptor T cell).

Talk to your healthcare provider and discuss what these results could mean for you.

Hear from a real EPKINLY patient

Michael, a real EPKINLY patient.

“I was capable of doing things that I used to do.”

Michael.Treated with EPKINLY

Information that the patient shares is his reflection, and his journey may not be emblematic of the treatment journey of other patients.

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), which is common during treatment with EPKINLY and can be serious or lead to death. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. Your first full dose of EPKINLY will be given on day 15 of your first cycle of treatment and you should be hospitalized for 24 hours after due to the risk of CRS and neurologic problems. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
  • Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. 

Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away. 

EPKINLY can cause other serious side effects, including:

  • Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, feeling weak or generally unwell, or confusion.
  • Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia and lymphopenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems. 

Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.

Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and 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. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.

The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets.

These are not all the possible side effects of EPKINLY. Review the Important Safety Information below and the Medication Guide for 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 the FDA at 1-800-FDA-1088.

We are dedicated to providing useful tools and resources to meet your needs, such as financial support and help preparing for your appointments.

When starting on EPKINLY, use the treatment tracker to record how you're feeling along with any questions you have for your healthcare team.

Man and woman sitting on a park bench swing and talking.

See how EPKINLY is given.