ADC Reports EMA’s Validation of MAA for Zynlonta to Treat R/R Diffuse Large B-Cell Lymphoma

Shots:

• The MAA is based on the P-II LOTIS-2 study evaluating Zynlonta (CD19-directed ADC) in 145 patients with r/r DLBCL following two or more prior lines of systemic therapy
• The results demonstrated 48.3% ORR; 24.1% CR rate; 24.1% PR rate; patients had a median time to response of 1.3mos. & m-DoR was 13.4mos.
• With the validation, the EMA’s CHMP will initiate the review process. Zynlonta has received the US FDA’s approval for the treatment of r/r large B-cell lymphoma after two or more lines of systemic therapy including DLBCL & the therapy is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies

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