AbbVie, Genmab receive European approval for Tepkinly in follicular lymphoma
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- 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., was co-developed and is co-marketed by AbbVie and Genmab.