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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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  • 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

  • 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

  • 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

  • FL is considered incurable with current available therapies

    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

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

    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

  • 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

  • EPKINLY + R2 could potentially become a new standard of care for follicular lymphoma

    80% confidence

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

    80% confidence

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

    80% confidence
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Morgan Stanley & Co. LLC
Two significantly different EPS values (10.21 vs 2.68 USD_per_share) are reported for Morgan Stanley on the same observation date (2025-12-31). Fact A specifies FY 2025, while Fact B's 'N/A' fiscal period is ambiguous. If both represent FY 2025 annual EPS, these values directly conflict. The magnitude of the difference (3.8x) is too large to attribute to rounding or minor calculation variations. The missing fiscal period in Fact B raises data quality concerns, but same-date observation + same attribute should reference the same period.
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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 | Finance Via News