Tepkinly - opinion on variation to marketing authorisation

Opinion

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

epcoritamab

Opinion

On 21 May 2026, 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 Tepkinly. The marketing authorisation holder for this medicinal product is Abbvie Deutschland GmbH & Co. KG.

The CHMP adopted an extension to an existing indication as follows:

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines 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 Tepkinly (VR/0000311043)

Adopted Reference Number: EMADOC-1700519818-3169911

Key facts

• Name of medicine:
  Tepkinly
• EMA product number:
  EMEA/H/C/005985
• Active substance:
  epcoritamab
• International non-proprietary name (INN) or common name:
  epcoritamab
• Therapeutic area (MeSH):
  Lymphoma, Large B-Cell, Diffuse
• Anatomical therapeutical chemical (ATC) code:
  L01FX27
• 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.

• Marketing authorisation holder:
  AbbVie Deutschland GmbH & Co. KG
• Date of opinion:
  21/05/2026
• Status:
  Positive