2023-05-19 12:59:30 ET
- AbbVie ( NYSE: ABBV ) and Genmab A/S ( GMAB ) announced Friday that the FDA approved Epkinly, a bispecific antibody therapy, as a late-line option for adults with white blood cell cancer large B-cell lymphoma (DLBCL).
- Specifically, the FDA’s label for Epkinly allows its use following two or more lines of systemic therapy for adults with relapsed or refractory (R/R) diffuse DLBCL.
- The decision based on the agency’s accelerated approval requires the developers to verify the clinical benefit of Epkinly in a confirmatory trial(s) for its continued approval.
- The FDA has issued its decision citing Epkinly’s impact on response rate and durability of response in DLBCL patients.
- The subcutaneously delivered drug is designed to bind T-cells and CD20+ lymphoma B-cells. As monotherapy, Epkinly has indicated a 65% overall response rate, 38% complete remission, and 15.6-month median duration of response in a pivotal Phase 2 trial for R/R DLBCL patients.
For further details see:
AbbVie, Genmab granted FDA nod for lymphoma therapy