Company: GNMSF
Filing Date: 2025-08-07
Form Type: 6-K
Source: 0001434265-25-000063
Chunk: 18

Company: GENMAB A/S
Filing Date: 2025-08-07
Form: 6-K
Chunk 18
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&J were $6,776 million in the first six months of 2025

Daratumumab is a human monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells and is also expressed by AL amyloidosis plasma cells. Genmab used technology licensed from Medarex to generate the CD38 antibody. Daratumumab is being developed and commercialized by J&J under an exclusive worldwide license from Genmab. Under the terms of the agreement, Genmab receives royalties between 12% and 20% with J&J reducing such royalty payments for Genmab’s share of J&J’s royalty payments made to Halozyme; payments are further reduced in countries and territories where there are no relevant patents. Daratumumab (marketed as DARZALEX for IV administration and as DARZALEX FASPRO in the U.S. and as DARZALEX SC in Europe for SC administration) is approved in a large number of territories for the treatment of adult patients with certain multiple myeloma indications and is the only approved therapy in the U.S., Europe and Japan for the treatment of adult patients with AL amyloidosis.

In June 2025 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of a new indication for DARZALEX SC as monotherapy for the treatment of adult patients with smoldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. The European Commission subsequently approved this indication in July 2025, making DARZALEX SC the first licensed treatment for patients with high-risk SMM. The CHMP recommendation and approval were supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM. In November 2024, J&J also submitted a sBLA to the FDA seeking approval for daratumumab SC in this indication in the U.S. Please consult the European Summary of Product Characteristics for DARZALEX and DARZALEX SC and the U.S. Prescribing Information for DARZALEX and DARZALEX FASPRO for the labeled indication and safety information.

Kesimpta (ofatumumab) – Approved for the treatment of RMS