AbbVie’s epcoritamab granted priority review by FDA in follicular lymphoma

AbbVie (ABBV) announced that the FDA has granted Priority Review of the supplemental Biologics License Application – sBLA – for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody for the treatment of adult relapsed or refractory follicular lymphoma after two or more lines of therapy. If approved, epcoritamab-bysp will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy, marking its second indication following FDA and European Medicines Agency – EMA – approval of R/R third-line diffuse large B-cell lymphoma treatment. This designation shortens the review period to six months compared to 10 months for Standard Review. In addition, the investigational R/R FL indication was granted Breakthrough Therapy Designation by the FDA and was submitted to the EMA in November 2023. The sBLA is based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which demonstrated high overall and complete responses in patients with R/R FL after two or more lines of therapy treated with epcoritamab. Epcoritamab is being co-developed by AbbVie and Genmab (GMAB) as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.