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 (NASDAQ: GMAB) and AbbVie Inc (NYSE: 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
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This article FDA Approves AbbVie/Genmab's Cancer Drug As First Bispecific Antibody For Type Of Lymphoma In Adult Patients originally appeared on Benzinga.com
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