Unique New Lymphoma Treatment Priced at $37,500 Monthly

Abbvie and Genmab’s Epkinly (epcoritamab-bysp), a first-of-its-kind treatment for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), will be priced at $37,500 per month, executives told Formulary Watch.

Epkinly is the first and only T-cell engaging bispecific antibody to treat adult patients with relapsed or refractory (R/R) DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies, AbbVie said.

AbbVie announced on May 19 that the FDA had approved the drug.

Jan van de Winkel, Ph.D.

The new treatment offers “a potential standard of care for patients with limited treatment options against this aggressive disease,” Jan van de Winkel, Ph.D., president and CEO of Genmab, and Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head hematology for AbbVie, said in an email to Formulary Watch.

"As a nonchemotherapy, single-agent treatment for DLBCL patients, we hope that Epkinly can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie.

Mariana Cota Stirner, M.D., Ph.D.

The $37,500-per-month wholesale acquisition cost (WAC) price of Epkinly “reflects the innovation behind our science, its potential impact on patients, and the critical importance of bringing that science to patients,” van de Winkel and Cota Stirner said.

“Our priority is ensuring that patients who are prescribed Epkinly have access to it, and so we will work with stakeholders across the healthcare system and have comprehensive support services in place that are appropriate to each patient’s needs,” the executives said.

The WAC is based on an average duration of therapy in clinical trials of around nine months. After nine months, the average price per month decreases as dosing becomes less frequent, van de Winkel and Cota Stirner noted.

The two companies are committed to making Epkinly available to patients within the coming days, they added.

The new treatment is approved under the FDA's accelerated approval program based on response rate and durability of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 30% off all NHL cases and comprising an estimated 30,400 U.S. cases in 2022, van de Winkel and Stirner said.

FDA’s approval is based on a Phase 2 study in which subcutaneous Epkinly monotherapy demonstrated responses in challenging-to-treat, relapsed or refractory DLBCL patients who have received at least two prior treatments. An overall response (complete or partial response) was seen in 61% of patients and 38% achieved complete remission.

Epkinly is injected subcutaneously in 28-day cycles until disease progression or unacceptable toxicity. The recommended dose is detailed in the prescribing information.

Epkinly’s prescribing information has a boxed warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections and cytopenias.