What You Should Know
- With the newest FDA approvals, Epkinly becomes the first bispecific antibody regimen available for many people with relapsed or refractory follicular lymphoma.
- The combination of strong disease-control data, manageable side effects, and subcutaneous delivery makes it a realistic, often preferable option for many patients.
- For patients and families, that could mean longer remissions, fewer toxic chemotherapies, and more of life outside the hospital.
At the nation’s largest blood cancer meeting in Orlando, one therapy stole the spotlight: Epkinly. This emerging drug combination is reshaping the outlook for patients with relapsed or refractory non-Hodgkin lymphoma, particularly Follicular Lymphoma (FL) and Diffuse Large B‑Cell Lymphoma (DLBCL). This new approach to fighting lymphoma offers new hope beyond traditional chemotherapy.
For patients and families, Epkinly works differently from traditional chemotherapy and may offer better control with greater flexibility.
What Is Epkinly — A New Approach to Fighting Lymphoma
Epkinly (generic name epcoritamab-bysp) is a bispecific T-cell engager. In plain speak: it’s a drug designed to bring two types of cells together: a patient’s own immune T-cells on one side, and the lymphoma B-cells on the other, and prompt the T-cells to kill the cancer cells.
Unlike many other treatments, Epkinly is given subcutaneously (a shot under the skin), which makes it more convenient than traditional IV infusions.
Before 2025, Epkinly was already approved for people whose lymphoma had returned or not responded after two or more prior therapies, including certain types of DLBCL and FL.
What’s new, and why the oncology world is paying close attention, is that in November 2025, the U.S. FDA approved Epkinly in combination with other standard lymphoma drugs (rituximab + lenalidomide) for relapsed or refractory follicular lymphoma, even earlier in the treatment course, as a second-line option. It is now the first bispecific antibody combination ever approved for FL in that setting.
What the Evidence Shows — Strong Results From the New Trial
The approval is based on results from the phase 3 “EPCORE FL-1” trial, which enrolled 488 adults with relapsed or refractory follicular lymphoma. Participants were randomized to receive either:
- Epkinly + rituximab + lenalidomide or
- Rituximab + lenalidomide alone — the control group.
Here’s what emerged as exciting results:
- The risk of disease progression or death was reduced by 79% in the Epkinly arm compared with the control group.
At the time of interim analysis (i.e, before the study is completed), median progression-free survival (period of time when the patients remain with stable disease) was not reached in the Epkinly group, meaning more than half of the patients were still progression-free at the time of analysis, vs 11.2 months in the control arm. The three-drug combination worked much better than the two-drug treatment, and the results lasted longer.
These results suggest that adding Epkinly significantly improves how long a patient can go without the lymphoma progressing — and does so with a manageable safety profile. That’s why many lymphoma experts say Epkinly + standard treatment will likely become the main second-line option for FL.
What Doctors and Patients Are Weighing When Considering Epkinly
Even with strong data, using Epkinly involves thoughtful decision-making. Some of the factors doctors and patients look at when discussing it include:
How aggressive or repetitive is the patient’s lymphoma?
Because the Epkinly-based regimen showed the biggest benefit in people who already had relapsed or refractory disease, it’s especially appealing when the disease has returned quickly or repeatedly.
For people whose follicular lymphoma comes back within two years of their first treatment, the disease can be more aggressive and harder to control. The combination of Epkinly, lenalidomide, and rituximab offers a chemo-free approach that can shrink the lymphoma effectively and keep it under control longer.
Tolerability and safety profile.
The randomized trial did not reveal any unexpected or new safety concerns.
Convenience and lifestyle considerations.
Because Epkinly is subcutaneous (not a long IV infusion), it can be more convenient for people concerned about time, travel, and hospital stays.
Prior treatments and goals of care.
If a patient has already had multiple therapies or is prone to chemotherapy toxicity, Epkinly offers a potentially effective, chemo-sparing alternative that may preserve quality of life for longer.
In short, Epkinly doesn’t replace all prior options, but for many patients, it offers a powerful new choice that balances effectiveness with the practicality of a longer remission.
What Patients Should Do Now
Epkinly’s recent FDA approval marks a milestone: it brings a potent, T-cell-engaging immunotherapy into a position earlier in the treatment journey for follicular lymphoma. For patients and families, that could mean longer remissions, fewer toxic chemotherapies, and more of life outside the hospital.
That said, Epkinly is part of a broader, evolving landscape. Additional trials are ongoing to test it in other lymphomas, earlier disease settings, and in combination with different therapies.
If you or a loved one has relapsed follicular lymphoma, it’s a good time to talk with your oncologist about whether Epkinly might be a fit, especially now that it’s FDA-approved in combination with rituximab + lenalidomide.
