vzphotos/iStock Editorial via Getty Images The European Commission has given AbbVie ( NYSE: ABBV ) and Genmab ( GMAB ) conditional approval for Tepkinly (epcoritamab) as monotherapy for follicular lymphoma after at least two lines of systemic therapy. The approval is the first for a T-cell bispecific antibody in this patient population. Approval was based on data from a phase 1/2 trial that showed an overall response rate and a complete response rate of 63%.
At a median follow-up of 16.2 months, the median duration of response was 21.4 months.
The drug was already approved in the EU for large B-cell lymphoma. The treatment, which is marketed as Epkinly in the U.S.
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