The European Commission granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of prior therapy. Tepkinly is the only subcutaneous T-cell engaging bispecific antibody approved to treat both r/r FL and r/r diffuse large B-cell lymphoma in the EU, as well as the European Economic Area countries (Iceland, Liechtenstein, Norway) and Northern Ireland.
FDA accepted for review the resubmission of the Regeneron Pharmaceuticals, Inc.’s Biologics License Application for Ordspono (odronextamab) in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The target action date for the FDA decision is July 30.
