Genmab A/S to Submit Supplemental Biologics License Application to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed Refractory Follicular Lymphoma
Genmab A/S announced its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and Lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R R) follicular lymphoma (FL), following at least one prior systemic therapy. Epcoritamab is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with R R FL after two or more lines of systemic therapy. EpcoritAMab to Submit Supplemental Biologics License Application (SBLA) to U.S. Food and drug Administration for Epcoritamab Plus Rituximab and Lenalomide (R2) in Patients with Relapsed Refractory Follicular Lymphoma (FL) manufacturing, the lack of market acceptance of products, inability to manage growth, the competitive environment in relation to business area and markets, inability to attract and retainably qualified personnel, the unenforceability or lack of protection of patents and proprietary rights.
Genmab A/S specializes in the research and development of human and therapeutic antibodies intended for treating cancers, infectious diseases, rheumatoid arthritis, etc. Net sales break down by type of income as follows:
- royalties (83.4%);
- income from sales of products (10.7%);
- other (5.9%): primarily income from partnership agreement.
Net sales are distributed geographically as follows: Denmark (89.4%), the United States (4.9%) and Japan (5.7%).
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Genmab A/S to Submit Supplemental Biologics License Application to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed Refractory Follicular Lymphoma
