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FDA to Speed Up Epkinly Development for Relapsed/Refractory Follicular Lymphoma


The Food and Drug Administration granted a Breakthrough Therapy Designation to Epkinly to treat patients with relapsed or refractory follicular lymphoma.

image of FDA poster

The Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation to Epkinly (epcoritamab-bysp) for the treatment of patients with relapsed (when cancer comes back after treatment) or refractory (when cancer stops responding to treatment) follicular lymphoma who previously underwent two or more prior therapies, according to AbbVie, the co-manufacturer of the drug.

Per the FDA’s website, Breakthrough Therapy Designations speed up the development and review of treatments for serious conditions. The agency grants the designation when the trial data shows that the regimen in question may offer substantial improvements in outcomes compared with therapies that are currently available.

In this instance, the Breakthrough Therapy Designation is based off findings from the phase 1/2 EPCORE NHL-1 clinical trial that is evaluating the safety and efficacy (cancer-fighting abilities) of Epkinly in 128 adults with relapsed, progressive or refractory CD20-positive mature B-cell non-Hodgkin lymphoma, which includes follicular lymphoma. Epkinly was administered subcutaneously, meaning that it was injected under the skin.

Top line findings from EPCORE NHL-1 that were announced in June 2023 showed that 82% of patients responded to treatment with Epkinly, meaning that their disease shrunk — a percentage that the researchers deemed was high enough to determine that the drug worked. At the time, a duration of response was not yet reached, indicating that most patients had not experienced disease progression, so an average time could not be calculated.

Regarding side effects, the most common side effect observed was cytokine release syndrome (CRS), which occurred in 66.4% of patients, including 1.6% who experienced moderate to severe (grade 3 or higher) CRS. CRS is a side effect that occurs when too many inflammatory molecules, called cytokines, flood into the blood stream.

Now, according to AbbVie, updated results from the EPCORE NHL-1 trial will be presented at the upcoming American Society of Hematology Annual Meeting in December.

READ MORE:FDA Approves Epkinly for Relapsed/Refractory DLBCL

Epkinly is a IgG1-bispecific antibody, which is a type of drug that works by binding to the immunoglobulin G antibodies found in the blood that play an important role in the immune system’s ability to find and destroy threats and invaders, such as viruses or bacteria. High levels of immunoglobulin G are associated with certain types of blood cancers, such as non-Hodgkin lymphoma —including follicular lymphoma, which is the second most common type of non-Hodgkin lymphoma, making up for approximately 20 to 30% of cases worldwide, according to the release.

"The FDA granted (Breakthrough Therapy Designation) … (is an) important step in our commitment to improving the lives of patients with relapsed/refractory follicular lymphoma, a complex blood cancer with limited treatment options," Dr. Mariana Cota Stirner, vice president, therapeutic area head for hematology, AbbVie, said in the press release. "Together with Genmab, we are continuing to investigate (Epkinly) as a potential core therapy for multiple B-cell malignancies, including diffuse large B-cell lymphoma and now follicular lymphoma."

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Dr. Lauren Pinter-Brown