AbbVie seeks approval for epcoritamab to treat adults with relapsed or refractory (R/R) FL after two or more lines of therapy and this Priority Review has reduced the review time to just six months
An image of AbbVie’s US headquarters. (Credit: AbbVie Inc.)
AbbVie said that the US Food and Drug Administration (FDA) has granted Priority Review of its supplemental Biologics License Application (sBLA) for epcoritamab-bysp (Epkinly) for treating certain follicular lymphoma (FL) patients.
Epcoritamab is an investigational T-cell engaging bispecific antibody that is administered subcutaneously.
AbbVie seeks approval for epcoritamab to treat adults with relapsed or refractory (R/R) FL after two or more lines of therapy.
With this Priority Review, the review time for the antibody has been reduced to six months in comparison to ten months for standard review.
Earlier, the US FDA and European Medicines Agency (EMA) approved Epkinly for R/R third-line diffuse large B-cell lymphoma (DLBCL) treatment.
The sBLA was supported by the results from Phase 1/2 open-label, multi-centre EPCORE NHL-1 clinical trial.
The FL cohort of the trial assessed epcoritamab in R/R FL patients after two or more lines of systemic therapy.
AbbVie said that the investigational candidate demonstrated high overall and complete treatment responses in these patients.
It showed an overall response rate (ORR) was 82% as confirmed by an independent review committee (IRC).
The optimisation cohort assessed a different step-up dosage to lessen the likelihood and intensity of cytokine release syndrome (CRS) and to facilitate possible outpatient administration.
AbbVie hematology therapeutic area head VP Mariana Stirner said: “Despite new treatment options, follicular lymphoma remains incurable and difficult to treat. Unfortunately, relapse is common and additional lines of treatment are needed.
“Together with our partner Genmab, we are committed to further advancing epcoritamab as a core lymphoma therapy.”
AbbVie and Genmab are co-developing epcoritamab as part of their oncology partnership.
The businesses will split commercial duties in the US and Japan, with AbbVie handling additional worldwide marketing.
Both firms will seek additional international regulatory approvals for the experimental R/R FL indication and additional approvals for the R/R DLBCL indication.