Tepkinly receives second EC approval

The European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

Tepkinly is being is co-developed by US pharma major AbbVie (NYSE: ABBV) and Denmark’s Genmab (OMX: GEN) as part of the companies' oncology collaboration, worth a potential $3.15 to the latter.

Tepkinly 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 the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.