FDA approves Genmab and AbbVie’s Epkinly

The US Food and Drug Administration (FDA) has approved US pharma major AbbVie (NYSE: ABBV) and Denmark’s Genmab (Nasdaq: GMAB) Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two is the first and only bispecific antibody approved in the USA to treat both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL), the companies noted.

FL is the second most common form of non-Hodgkin’s lymphoma (NHL), and about 15,000 people develop FL each year in the USA, and is considered incurable with conventional therapy and patients who achieve remission also often experience relapse. Patients with R/R FL face significant treatment challenges, especially in the third-line setting where there is currently no standard of care.

Epkinly has demonstrated deep and durable responses that can last more than year for many patients, and it also provides the convenience of subcutaneous administration.