Epkinly: FDA Approves New Bispecific Antibody Option for Relapsed or Refractory Follicular Lymphoma

Epkinly (epcoritamab-bysp) is a type of cancer treatment called a bispecific antibody that helps your immune system find and destroy certain cancer cells by connecting immune cells (T cells) to cancer cells (B cells). Epkinly is now approved to be used with two other medicines – rituximab and lenalidomide – to treat adults with a form of blood cancer known as follicular lymphoma (FL) that has come back (relapsed) or didn’t respond to earlier treatment (refractory).

The FDA has also granted full (traditional) approval for epcoritamab-bysp alone for FL that has returned or not responded after at least two previous treatments. This monotherapy use previously held an accelerated approval in 2024.

FL is a slow-growing form of non-Hodgkin’s lymphoma that arises from B lymphocytes (B cells). While it may respond to treatment at first, it often returns, and the remissions get shorter each time. In some cases, it can turn into a more aggressive type of lymphoma, which is harder to treat and linked to poor survival. About 15,000 people in the U.S. are diagnosed with FL each year.

What makes this approval important is that it’s the first time a bispecific antibody has been approved to be used with other medicines relatively early in the treatment. It also offers a treatment option that doesn’t involve chemotherapy and can be given in an outpatient setting, which may be more convenient for many people.

Why Was It Approved?

Epkinly was approved because a clinical study involving people with FL that had come back or didn’t respond after at least one earlier treatment showed that the Epkinly, rituximab, and lenalidomide combination worked better than standard treatment. The study looked at how long people lived without their cancer getting worse and how many people responded to treatment.

People who received Epkinly along with rituximab and lenalidomide (a combination known as R2) showed better results than those who got R2 alone. In the Epkinly group, 89% of people responded to treatment, and 74% had no signs of cancer after treatment. In comparison, 74% of people responded to R2 alone, and 43% had no signs of cancer after treatment. Also, the risk of the cancer getting worse or leading to death was reduced by about 79% in the Epkinly group.

The most common side effects are rashes, tiredness, infections, injection-site reactions, constipation, diarrhea, fever, and low counts of white blood cells and platelets. A serious immune reaction called cytokine release syndrome (CRS) occurred in some patients, but most cases were mild. A rare but serious brain-related side effect known as immune effector cell-associated neurotoxicity syndrome (ICANS), marked by symptoms such as confusion or trouble speaking, was reported only occasionally.

What Do I Need To Know?

Epkinly is given as a shot under the skin, usually in the lower part of your stomach area (abdomen) or thigh. It’s used together with rituximab and lenalidomide for up to 12 treatment cycles, with each cycle lasting about four weeks. The first cycle includes a step-up dosing schedule to help lower the risk of serious side effects like CRS.

You may need to stay in the hospital after your first full dose so your health care provider can watch for side effects. If you feel drowsy or less alert, avoid driving, using heavy machinery, or engaging in any risky activity until you feel better.

Your health care provider will check your blood counts and monitor you for signs of infection or other problems during treatment. Before starting Epkinly, be sure to tell your health care provider if you have an infection and about all the medicines that you take. If you are pregnant, breastfeeding, or planning to become pregnant, talk to your health care provider. This medicine may harm your fetus, and you should not breastfeed or get pregnant during the treatment and for four months after your last dose.

Contact your health care provider right away if you notice problems like trouble speaking, walking, or writing; confusion; unusual sleepiness; extreme tiredness; weakness; shaking; seizures; or memory issues, as they can be symptoms of ICANS. Inform your health care provider if you have a fever of 100.4 F (38 C) or higher and chills, a sore throat, a cough, trouble breathing, pain while urinating, a rash, dizziness or lightheadedness, unusual bleeding or bruising, or a fast heartbeat. These could be signs of other serious side effects.