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Source document· November 18, 2025

AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma

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AbbVie Announces U.S…
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  • EPKINLY + R2 could potentially become a new standard of care for follicular lymphoma

    80% confidence

  • FL is considered incurable with current available therapies

    80% confidence

  • EPKINLY is now the first bispecific antibody available for patients with follicular lymphoma in the second-line plus setting

    80% confidence

  • Recurrent follicular lymphoma can be an incurable, complex and persistent disease, creating a clear need for additional treatments that can change its course earlier in the treatment journey

    80% confidence

  • The results shown with EPKINLY + R2 in the EPCORE FL-1 study are incredibly meaningful, demonstrating durable responses compared to patients treated with R2 alone

    80% confidence

  • New options are needed to improve outcomes for patients with relapsed or refractory disease

    80% confidence

  • The safety profile of EPKINLY + R2 in the EPCORE FL-1 study was generally consistent with the known safety profiles of the individual regimens

    80% confidence

  • EPKINLY plus rituximab and lenalidomide is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy

    80% confidence

  • In the Phase 3 EPCORE FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete response

    80% confidence

  • With a bispecific-based therapy that can be administered in a variety of medical settings, patients have the possibility of accessing this treatment at sites of care closer to where they live

    80% confidence

  • This approval marks third indication for EPKINLY and first-ever FDA approval for a bispecific combination therapy in lymphoma

    80% confidence
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Q4 2026 Biotech Catalyst Cluster: Late-Stage Data and PDUFA Dates Converge
Early-to-mid November 2026 is a dense run of clinical readouts and Q3 earnings at AHA, AASLD, ACR and ASH. Mid-cap biotechs (Vir, Mineralys, Arrowhead, Oryzon, Novartis, J&J) are reporting data that feeds into regulatory decisions. The next ones are the ivonescimab BLA (Nov 14) and the lorundrostat PDUFA (Dec 22), followed by ECLIPSE 2/3 and Maritime-1 readouts in Q1 2027. The list also includes an unrelated delisting track (EGM Nov 19, application Jan 25, 2027), and the facts have no AI or fintech content.
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Satellite-Terrestrial Network Integration Acceleration
Increased investment and launches in hybrid satellite-cellular networks across telecom industry; competitive responses from other carriers; regulatory activity around satellite spectrum; expansion of emergency/rural connectivity use cases
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Ford Motor Company
Both facts give cash for Ford Motor Company at the same point in time (2025-12-31; FY 2025 year-end and Q4 2025 year-end are the same date). Both are labelled USD, but the values are 23,356,000,000 and 23.356, which cannot both be true in USD. The two numbers agree once the second is read as billions (23.356 bn = 23,356,000,000), so the economic content is consistent and the conflict is a unit/scale error in the Q4 2025 record. The period is not the reason for the conflict: a Q4 and an FY figure at the same year-end date should match.
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AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma: Source | Via News | fr.via.news