AbbVie's Tepkinly Gets Conditional EU Approval For Relapsed Or Refractory Follicular Lymphoma

(RTTNews) - AbbVie (ABBV) announced that the European Commission 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 prior therapy.

According to the company, Tepkinly is the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both relapsed or refractory follicular lymphoma and relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.

Epcoritamab, approved under the brand name Epkinly in the United States and Tepkinly in the European Union, has received regulatory approval for certain lymphoma indications in several countries.

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the R/R FL indication and the R/R DLBCL indication.

AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets. Both Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy and in combination across lines of therapy in a range of hematologic malignancies.

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