FDA Approves AbbVie/Genmab's Cancer Drug As First Bispecific Antibody For Type Of Lymphoma In Adult Patients

The FDA has approved Epkinly (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Epkinly is being co-developed and co-commercialized by Genmab A/S GMAB and AbbVie Inc ABBV as part of the companies' oncology collaboration.

Epkinly features a dual-targeted approach continuously binding to T-cells and CD20+ lymphoma B-cells. 

In the pivotal Phase 2 study, subcutaneous Epkinly monotherapy demonstrated responses in challenging-to-treat, relapsed, or refractory DLBCL patients who have received at least two prior treatments. 

The overall response was seen in 61% of patients, and 38% achieved complete remission.

The median duration of response was 15.6 months.

The drug is approved in the U.S. based on patient response data. A study is ongoing to confirm the clinical benefit of Epkinly.

Price Action: GMAB shares are up 1.40% at $41.25, and ABBV shares are up 1.54% at $145.65 on the last check Friday.

Photo by Gerd Altmann from Pixabay