AbbVie’s EPKINLY gains FDA approval for relapsed follicular lymphoma

USA— AbbVie, an American pharmaceutical company based in North Chicago, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for EPKINLY (epcoritamab-bysp).

This marks a milestone as EPKINLY becomes the first T-cell engaging bispecific antibody administered subcutaneously for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.

Epcoritamab, co-developed by AbbVie and Genmab under their oncology collaboration, has garnered attention for its innovative approach to treating FL.

 AbbVie will manage global commercialization, with joint responsibilities alongside Genmab in the U.S. and Japan.

The FDA’s approval is rooted in findings from the Phase 1/2 EPCORE® NHL-1 clinical trial, in which EPKINLY demonstrated both safety and efficacy in 127 adult patients with R/R FL.

Many of these patients had double refractory disease after receiving a median of three prior lines of therapy.

The approval under the FDA’s Accelerated Approval program hinges on EPKINLY’s overall response rate (ORR) and the durability of these responses.

However, continued approval is contingent upon further validating its clinical benefit in confirmatory trials.

During the approval announcement, Dr. Mariana Cota Stirner, Vice President, and therapeutic area head for AbbVie’s hematology, emphasized EPKINLY’s approval’s pivotal nature.

She highlighted that this novel treatment option offers hope to patients facing the challenges of R/R follicular lymphoma, particularly after experiencing treatment failures with other therapies.

Stirner underscored the significant clinical outcomes observed, noting deep and sustained responses in many patients.

She also praised the convenience of EPKINLY’s subcutaneous dosing regimen, which allows outpatient administration through a 3-step-up dosing protocol.

Dr. Jeff Sharman, Disease Chair of Hematology Research at the Sarah Cannon Research Institute (SCRI), echoed these sentiments, stressing the critical need for effective treatments in R/R follicular lymphoma.

He pointed to promising results from the EPCORE NHL-1 trial, which suggest that EPKINLY could emerge as a pivotal treatment option not only for FL but potentially for other B-cell malignancies.

Lee Greenberger, chief scientific officer at The Leukemia & Lymphoma Society, emphasized the approval’s significance in expanding treatment options for people with follicular lymphoma.

He welcomed EPKINLY’s approval as an additional tool for physicians grappling with the complexities of treating this challenging cancer. 

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook