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BioWorld - Thursday, January 1, 2026
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Home » ADC wins FDA accelerated approval for Zynlonta in diffuse large B-cell lymphoma
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ADC wins FDA accelerated approval for Zynlonta in diffuse large B-cell lymphoma

April 23, 2021
By Michael Fitzhugh
Nearly a full month ahead of the PDUFA date, ADC Therapeutics SA said Friday the FDA has granted accelerated approval for Zynlonta (loncastuximab tesirine), a CD19-targeted antibody-drug conjugate for the single-agent treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. The approved indication includes the treatment of patients with diffuse large B-cell lymphoma not otherwise specified and those with DLBCL arising from low grade lymphoma and high grade B-cell lymphoma, which ADC's CEO Chris Martin said would be an important point of differentiation for the product.
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