Nebenwirkungen · Minjuvi
MINJUVI 200 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 12
HOS-147428 · Präparat HOS-099656
Immunogenicity In 245 patients treated with tafasitamab in the initial clinical studies, no treatment-emergent or treatment-boosted anti-tafasitamab antibodies were observed. Pre-existing anti-tafasitamab antibodies were detected in 17/245 patients (6.9%) with no impact on pharmacokinetics, efficacy or safety of tafasitamab. Anti-drug antibodies (ADAs) were tested in 327 patients with relapsed or refractory follicular lymphoma or relapsed or refractory marginal zone lymphoma who received tafasitamab in study inMIND. The incidence of tafasitamab treatment-emergent ADAs was 0.9% (3/327) using a bridging enzyme-linked immunosorbent assay. No neutralizing antibodies were detected. There was no apparent clinically meaningful effect of ADAs on the pharmacokinetics, pharmacodynamics, safety, or effectiveness of tafasitamab over the median treatment duration of 322.5 days.
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