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This medicinal product has been authorised under a 'conditional approval' scheme. This means that further evidence on this medicinal product is awaited.

LOTIS-2: For primary and secondary endpoints and full trial data

ZYNLONTA subgroup analysis demonstrated efficacy in patients with 3L+ R/R DLBCL after prior CD19-targeted CAR-T therapy1,2

LOTIS2 sub analysis

In patients with R/R DLBCL who had received prior CAR-T, the response rate with ZYNLONTA was similar to the overall LOTIS-2 population1,2

a Sub-group analyses were predefined, but were exploratory and not powered to determine statistical significance.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (for United Kingdom) and www.hpra.ie (for Republic of Ireland). Adverse events should also be reported to Swedish Orphan Biovitrum Ltd at [email protected] or Telephone +44 (0) 800 111 4754.

Abbreviations:
CAR-T: chimeric antigen receptor T-cell; CR: complete response; ORR: overall response rate; PR: partial response

References:
1. Caimi PF et al. Lancet Oncol 2021; 22: 790-800. 2. Caimi PF et al. Clinical Lymphoma, Myeloma and Leukemia. 2021; 5: e335-e339.

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