NORTH CHICAGO, Ill., Feb. 27, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody aimed at treating adult relapsed or refractory (R/R) follicular lymphoma (FL) post two or more lines of therapy. This follows the FDA's Breakthrough Therapy Designation (BTD) for the investigational indication in November 2023.
Breakthrough Designation and Priority Review
The FDA's Priority Review aims to expedite the approval process for therapies promising significant improvements in treating serious conditions. Epcoritamab-bysp, if approved, would be the first subcutaneous bispecific antibody for adults with R/R FL after two lines of prior therapy. The investigational therapy received Breakthrough Therapy Designation in November 2023 and has been submitted to the European Medicines Agency (EMA).
Clinical Trial Results
The sBLA submission draws on data from the Phase 1/2 EPCORE? NHL-1 clinical trial, demonstrating robust and enduring treatment responses in patients with R/R FL post multiple lines of therapy. Results from the trial's FL cohorts were presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023. Notably, an optimization cohort explored alternative dosing regimens to mitigate cytokine release syndrome (CRS) and facilitate potential outpatient administration.
Collaborative Development
Epcoritamab is a collaborative effort between AbbVie and Genmab within their oncology partnership. Commercial responsibilities will be shared in the U.S. and Japan, with AbbVie leading global commercialization efforts. Both companies are pursuing international regulatory approvals for the investigational R/R FL indication and additional approvals for R/R diffuse large B-cell lymphoma (DLBCL).
Key Points Summarized
- The FDA grants Priority Review for AbbVie's epcoritamab-bysp, a subcutaneously administered bispecific antibody, in treating adult relapsed or refractory follicular lymphoma (FL) post two or more lines of therapy.
- Breakthrough Therapy Designation was granted in November 2023, acknowledging the therapy's potential to address significant unmet medical needs.
- Clinical trial data from the Phase 1/2 EPCORE? NHL-1 trial support the sBLA submission, showcasing strong and durable treatment responses in R/R FL patients.
- Collaborative efforts between AbbVie and Genmab drive the development and commercialization of epcoritamab, targeting both U.S. and international regulatory approvals.
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