Minjuvi

tafasitamab · Incyte Biosciences Distribution B.V.
ORPHAN CONDITIONAL APPROVAL AUTHORISED IN THE EU

What Minjuvi is used for

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).

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
  • Conditional approval: approved on less complete data because the need is high; more data must follow.

Key facts

Brand
Minjuvi
Active substance
tafasitamab
Disease area
Lymphoma, Large B-Cell, Diffuse
Medicine group
Antineoplastic agents
ATC code
L01FX12
Marketing authorisation holder
Incyte Biosciences Distribution B.V.
Authorised in the EU since
2021

Official information

In the USA

Same active substance: Monjuvi

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Minjuvi used for?

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).

What is the active substance in Minjuvi?

Minjuvi contains tafasitamab.

Who makes Minjuvi?

The EU marketing authorisation holder is Incyte Biosciences Distribution B.V..

Is Minjuvi an orphan medicine?

Yes. Minjuvi is designated an orphan medicine in the EU, for a rare disease (Lymphoma, Large B-Cell, Diffuse).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.