2023: Bispecific Lymphoma Therapy

On This Day in Health: May 19, 2023

On May 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to epcoritamab, marketed as Epkinly, for certain relapsed or refractory aggressive B-cell lymphomas after two or more previous lines of systemic therapy. The covered diagnoses included diffuse large B-cell lymphoma and high-grade B-cell lymphoma, with further definitions in the indication. For adults whose cancer had returned or resisted earlier treatment, the decision created another option. It also introduced a bispecific antibody approach to this treatment setting, connecting knowledge of lymphoma cells with the ability to direct an immune response against them.

Epcoritamab recognizes two different targets. It binds CD20 on B cells and CD3 on T cells, bringing immune cells close to the cells being targeted. The medicine is administered by injection under the skin. It does not require the individualized cell collection and engineering involved in CAR T-cell therapy. These approaches share an interest in using immune activity against cancer, but their preparation and delivery differ. Understanding that difference helps explain what the May 19 approval actually added. Patients and clinical teams were receiving another manufactured medicine to consider, with its own schedule, monitoring requirements and evidence base.

The supporting EPCORE NHL-1 study evaluated people with previously treated B-cell lymphoma. In the FDA's main efficacy group of 148 patients, the overall response rate was 61 percent, with complete responses in 38 percent. Researchers also examined how long responses lasted. Those results supported accelerated approval rather than establishing a guaranteed outcome or a permanent cure. The original decision required confirmatory evidence of clinical benefit. Safety was equally consequential: the prescribing information warned about cytokine release syndrome and serious neurologic toxicity, while infections and low blood-cell counts also needed attention. Qualified healthcare professionals and appropriate medical support were essential to administering the treatment.

The anniversary is a reminder that an important cancer advance can be an additional route through a difficult treatment sequence. A patient who has already undergone several therapies needs more than the announcement of a new product. The relevant questions include whether the diagnosis matches the indication, what benefit is realistic and how the treatment will fit into the person's care. May 19 records an expansion of those choices for a defined lymphoma population. It also recognizes the research participants who supplied the response evidence and the teams responsible for translating it into safe practice. The achievement was meaningful precisely because it addressed a specific unmet need, while leaving room for further study.