Tepkinly receives positive CHMP opinion for R/R DLBCL

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European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The final European Commission decision on this indication for Tepkinly is anticipated later this year.

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The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. 
In the phase III STARGLO study of Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) versus Rituxan (rituximab) in combination with GemOx (R-GemOx) for people with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy, the Columvi regiment extended overall survival.

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