EU Approval Decision Imminent For First CD20xCD3 Bispecific Antibody
If Roche gets the nod from the European Medicines Agency for mosunetuzumab this week, it could become the first company to market a CD20xCD3 bispecific antibody for follicular lymphoma.
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The company has maintained faith in autologous CAR-Ts, and its latest data show early signs of strong efficacy and favorable tolerability, possibly enabling outpatient use.
Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.
The European Medicines Agency was this week deciding whether to grant accelerated assessment for glofitamab.