FDA Accepts for Priority Review the sBLA for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma
“While treatment for patients with relapsed and refractory follicular lymphoma has progressed, there remains an urgent need for new treatment options, particularly for patients who are considered difficult to treat due to relapse following standard therapies and other poor prognostic factors,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The acceptance of the epcoritamab application for Priority Review marks an important milestone toward potentially providing a new treatment option to patients affected by R/R follicular lymphoma. Together with AbbVie, we look forward to working with the FDA during the review and remain committed to developing epcoritamab as a potential future core therapy for B-cell malignancies.”
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