AbbVie, Genmab get breakthrough tag for lymphoma treatment

 AbbVie (NYSE: ABBV) today announced updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL).

The FDA has granted Breakthrough Therapy Designation (BTD) to epcoritamab-bysp (EPKINLY®) for the treatment of adult patients with R/R FL after two or more therapies. Additionally, the EMA has validated a Type II application for epcoritamab (TEPKINLY®) for the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union.

https://www.prnewswire.com/news-releases/abbvie-announces-us-food-and-drug-administration-fda-and-european-medicines-agency-ema-updates-for-epcoritamab-epkinlytepkinly-for-the-treatment-of-relapsedrefractory-follicular-lymphoma-301997575.html