Basic Information
Zynlonta
Regulatory Information
EMEA/H/C/005685
December 20, 2022
September 15, 2022
3
October 1, 2024
Company Information
Sweden
SE-112 76 Stockholm
SWEDISH ORPHAN BIOVITRUM AB
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
Overview Summary
Zynlonta is a medicine for treating two types of B-cell lymphoma (a type of blood cancer): - diffuse large B-cell lymphoma (DLBCL); - high-grade B-cell lymphoma (HGBL). Zynlonta is used to treat adults with B-cell lymphoma that has come back (relapsed) after two or more treatments or that did not respond to previous treatment (refractory). Diffuse large B-cell lymphoma is rare, and Zynlonta was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 August 2021. Further information on the orphan designation can be found here: [https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2481](/en/medicines/human/orphan-designations/eu-3-21-2481) Zynlonta contains the active substance loncastuximab tesirine.