FDA Approves Expanded Use of AbbVie and Genmab's Epkinly for Follicular Lymphoma

AbbVie and Genmab have received FDA approval for their bispecific antibody, Epkinly (epcoritamab), to treat patients with relapsed or refractory follicular lymphoma. This new indication makes Epkinly the first and only T-cell-engaging bispecific antibody available for subcutaneous administration in this specific condition. The approval was granted through the FDA's accelerated pathway, requiring a confirmatory Phase III trial to validate its clinical benefits for continued approval.

Mariana Cota Stirner, who heads the hematology therapeutic area at AbbVie, emphasized that Epkinly now provides a new treatment option for patients who have not responded to other therapies. She highlighted its significant response rates and convenient dosing schedule, suggesting it could become a primary treatment for various B-cell malignancies. 

Epkinly operates by targeting both the CD3 protein on T cells and the CD20 antigen on B cells. This dual-targeting mechanism allows it to bring T cells into close proximity with malignant B cells, facilitating an anti-cancer response. Genmab initially developed Epkinly using its proprietary DuoBody platform. In June 2020, AbbVie entered into a partnership with Genmab, providing $750 million upfront and committing up to $3.15 billion in milestone payments to co-develop and commercialize the therapy. The first FDA approval for Epkinly came in May 2023 for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

The recent label expansion was supported by data from the Phase I/II EPCORE NHL-1 trial, involving 127 adults with follicular lymphoma who had undergone a median of three prior treatment lines. Many of these patients had double refractory disease. The trial results indicated an impressive objective response rate of 82%, with a 60% complete response rate and a 22% partial response rate. Notably, more than half of the responders maintained their response after a median follow-up of 14.8 months, although the study did not reach the median duration of response.

This FDA approval for Epkinly is particularly timely for AbbVie, as it follows the regulatory body's recent rejection of their Parkinson's disease therapy, ABBV-95, due to issues with a third-party manufacturer rather than concerns about the therapy's safety or efficacy. The approval also continues Genmab's successful regulatory streak, which includes a full FDA approval in April 2024 for its antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) developed in partnership with Pfizer for the treatment of recurrent or metastatic cervical cancer.

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