FDA grants accelerated approval to Brukinsa for R/R follicular lymphoma

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FDA granted accelerated approval to Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

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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. 

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