Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 28

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 28
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KINLY in Europe and other regions. 
Epcoritamab for the Treatment of B-cell Malignancies
DLBCL is the most common type of B-cell non-Hodgkin lymphoma (“B-NHL”) worldwide, accounting for approximately 25% - 30% of all NHL cases. In the U.S. there are approximately 25,000 new cases of DLBCL diagnosed each year. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men. DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.
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FL is typically a slow-growing form NHL of that arises from B-cell lymphocytes. FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world. FL is considered incurable, and there is no standard of care treatment for third-line or later FL. Patients who achieve remission also often experience relapse. In March 2022, November 2023 and September 2024, the FDA granted orphan-drug designation and BTD respectively to epcoritamab for the treatment of FL.
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Approvals and Results
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R/R DLBCL. Epcoritamab received accelerated FDA approval in May 2023, as EPKINLY, for the treatment of adult patients with R/R DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. EPKINLY was approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. In June 2023, epcoritamab was added to the National Comprehensive Cancer Network (“NCCN”) Clinical Practice Guidelines in Oncology for “B-cell Lymphomas” (Version 4.2023) for third-line