EC approval for AbbVie and Genmab lymphoma drug

The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly - from US drugmaker AbbVie (NYSE: ABBV) and Danish biotech Genmab (OMX: GEN) - is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as Liechtenstein, Norway and Iceland.

DLBCL is the most common type of B-cell non-Hodgkin's lymphoma worldwide. While patients may have access to chemoimmunotherapy regimens to treat their disease, they face limited treatment options, with few readily available, off-the-shelf medicines, especially for those whose disease has relapsed or become refractory to prior treatments.