Zynlonta (loncastuximab tesirine)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- loncastuximab tesirine
- Company
- Swedish Orphan Biovitrum AB
- Status
- Authorised
- Therapeutic area
- Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
- CHMP opinion
- Thu 15 Sep 2022
- EU approval
- Tue 20 Dec 2022
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005685
- ATC
- L01FX22
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.