Tecvayli - opinion on variation to marketing authorisation

Opinion

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

teclistamab

Opinion

On 25 June 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 Tecvayli. The marketing authorisation holder for this medicinal product is Janssen Cilag International.

The CHMP adopted a new indication as follows:

Tecvayli is indicated in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

For information, the full indications for Tecvayli will be as follows:

Tecvayli is indicated 

• in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
• as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last 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.

CHMP post-authorisation summary of positive opinion for Tecvayli (VR-0000322279)

Reference Number: EMADOC-1700519818-3256178

Key facts

• Name of medicine:
  Tecvayli
• EMA product number:
  EMEA/H/C/005865
• International non-proprietary name (INN) or common name:
  teclistamab
• Therapeutic area (MeSH):
  Multiple Myeloma
• Anatomical therapeutical chemical (ATC) code:
  L01F
• 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.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation holder:
  Janssen-Cilag International N.V.
• Date of opinion:
  25/05/2026
• Status:
  Positive