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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• 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

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

  80% confidence

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

  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

• 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

• 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

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

  80% confidence

• 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

• 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