Minjuvi (tafasitamab)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tafasitamab
- Company
- Incyte Biosciences Distribution B.V.
- Status
- Authorised
- Therapeutic area
- Lymphoma, Large B-Cell, Diffuse
- CHMP opinion
- Thu 24 Jun 2021
- EU approval
- Thu 26 Aug 2021
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/005436
- ATC
- L01FX12
- Official record
- www.ema.europa.eu
Indication
Minjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
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.