FDA Grants Accelerated Approval for Second Epkinly Indication

The FDA has granted an accelerated approval for a second indication for Epkinly (epcoritamab-bysp) to treat adults with relapsed or refractory follicular lymphoma after two or more lines of prior therapy.

Follicular lymphoma is a slow-growing form of non-Hodgkin’s lymphoma that arises from B-lymphocytes. It accounts for 20% to 30% of all non-Hodgkin’s lymphoma cases.

Jeff Sharman, M.D.

“Patients with relapsed or refractory follicular lymphoma face significant treatment challenges, and there is currently no clear standard of care treatment available across practice settings,” Jeff Sharman, M.D., disease chair, Hematology Research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon, said in a news release.

Developed by AbbVie and Genmab, Epkinly was approved in May 2023 as a third-line therapy to treat patients with diffuse large B-cell lymphoma (DLBCL) treatment. Epkinly targets CD3 on the surface of T cells and CD20 on the surface of B cells.

For the B-cell lymphoma indication, Epkinly is a monthly therapy with a cost of $37,500 per month. The list price for the follicular lymphoma indication is $30,016 per month for the first full year of therapy. The average price per month decreases as dosing becomes less frequent– from weekly, to biweekly, to monthly, according to a company spokesperson.

Copay assistance is available through Genmab’s MyNavCare program. The current maximum benefit is $25,000 per year. In 2023, Epkinly generated $31 million in worldwide revenue for AbbVie.

Under the agreement with AbbVie, Genmab receives royalties of between 22% and 26% on net sales outside the United States and Japan. Genmab and AbbVie evenly split product sales in other territories.

The FDA approval is based on results from the phase 1/2 EPCORE NHL-1 clinical trial. Patients treated with Epkinly experienced 82% overall response rate, including 60% complete response rate at a median follow up of 17.4 months. An estimated 85% and 74% of patients who experienced a complete response remained responsive to treatment at 12 and 18 months, respectively.

The most common adverse reactions were injection site reactions, cytokine release syndrome, COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache.

A separate dose optimization cohort evaluated 86 patients at the recommended three-step dosage schedule to help mitigate cytokine release syndrome. For the first full dose of this three-step regimen, mandatory hospitalization was not required. There were no grade 3 cytokine release syndrome observed in patients with follicular lymphoma who received Epkinly with the three step-up dosage schedule.