AbbVie has secured full FDA approval for its bispecific antibody EPKINLY (epcoritamab‑bysp) in combination with rituximab and lenalidomide (R2) for adult patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy. The approval makes EPKINLY + R2 the first bispecific antibody combination therapy to receive regulatory clearance in this setting, offering a chemotherapy‑free outpatient option for a disease that has limited second‑line choices.
The Phase 3 EPCORE FL‑1 trial demonstrated a 79% reduction in the risk of disease progression or death (hazard ratio 0.21) and an overall response rate of 89% for EPKINLY + R2 versus 74% for R2 alone. Complete response rates were 74% for the combination compared with 43% for R2 alone, underscoring the clinical advantage of adding the bispecific antibody to standard therapy.
Strategically, the approval expands AbbVie’s oncology portfolio and aligns with its bispecific antibody development strategy. Follicular lymphoma affects roughly 15,000 new U.S. patients each year; the addition of a chemotherapy‑free regimen positions AbbVie to capture a meaningful share of this market and to differentiate its product line in a crowded therapeutic landscape.
Financially, AbbVie’s Q3 2025 oncology revenue reached $1.682 billion, while total company revenue was $15.776 billion, up 9.1% year‑over‑year. The new indication is expected to add a significant revenue stream, reinforcing the company’s growth trajectory and supporting its recent dividend increase announced by CEO Robert A. Michael.
Management emphasized the clinical and commercial impact of the approval. Daejin Abidoye, MD, AbbVie’s VP of Therapeutic Area Head for Oncology, said, “With this approval, EPKINLY is now the first bispecific antibody available for patients with follicular lymphoma in the second‑line plus setting. New options are needed to improve outcomes for patients with relapsed or refractory disease.” CEO Michael noted the company’s confidence in its overall outlook, citing the approval as part of a broader strategy to drive future revenue growth.
The approval follows EPKINLY’s accelerated approval for monotherapy in June 2024 and is the result of a partnership with Genmab, which shares commercialization responsibilities in certain regions. Safety data from the trial are consistent with the known profiles of the individual agents; common adverse events include cytokine release syndrome, upper respiratory infections, fatigue, and injection‑site reactions, with boxed warnings for CRS and immune‑effector cell‑associated neurotoxicity syndrome.
In the competitive arena, Regeneron’s odronextamab received a complete response letter for a similar indication, highlighting the regulatory scrutiny in this space. AbbVie’s first bispecific antibody combination therapy, backed by robust clinical data and a chemotherapy‑free regimen, positions it favorably to meet the unmet needs of patients and to capture market share in a growing follicular lymphoma market.
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