Minjuvi - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

tafasitamab

Opinion

On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Minjuvi. The marketing authorisation holder for this medicinal product is Incyte Biosciences Distribution B.V.

The CHMP adopted a new indication as follows:

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).

Minjuvi is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold.

CHMP post-authorisation summary of positive opinion for Minjuvi (EMAVR0000255975)

Adopted Reference Number: EMADOC-1700519818-2579167

Key facts

• Name of medicine:
  Minjuvi
• EMA product number:
  EMEA/H/C/005436
• Active substance:
  tafasitamab
• International non-proprietary name (INN) or common name:
  tafasitamab
• Therapeutic area (MeSH):
  Lymphoma, Large B-Cell, Diffuse
• Anatomical therapeutical chemical (ATC) code:
  L01FX12
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Incyte Biosciences Distribution B.V.
• Date of opinion:
  13/11/2025
• Status:
  Positive