Lynozyfic

Opinion

EMA has issued an opinion on this medicine

linvoseltamab

Overview

On 27 February 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Lynozyfic, intended for the treatment of patients with relapsed and refractory multiple myelomawho have received at least three prior therapies.

The applicant for this medicinal product is Regeneron Ireland DAC.

Lynozyfic will be available as a 5 mg or 200 mg concentrate for solution for infusion. The active substance of Lynozyfic is linvoseltamab, a bispecific monoclonal antibody (ATC code: not yet assigned). Lynozyfic targets CD3, a receptor expressed on the surface of T cells, and BCMA, expressed on the surface of plasma cells, including malignant multiple myeloma cells.

The benefit of Lynozyfic is its ability to induce a partial or complete response in patients with relapsed or refractory multiple myeloma, as shown in a phase 2, open-label study. The most common side effects with Lynozyfic are musculoskeletal pain, cytokine release syndrome, neutropenia, cough, diarrhoea, anaemia, fatigue, pneumonia and upper respiratory tract infection.

The full indication is:

Lynozyfic is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

Treatment with Lynozyfic should be initiated and supervised by physicians experienced in the treatment of multiple myeloma.

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

CHMP summary of positive opinion for Lynozyfic

AdoptedReference Number: EMA/CHMP/48992/2025

Product details

• Name of medicine:
  Lynozyfic
• Active substance:
  linvoseltamab
• International non-proprietary name (INN) or common name:
  linvoseltamab
• Therapeutic area (MeSH):
  Multiple Myeloma
• Anatomical therapeutic chemical (ATC) code:
  L01FX
• EMA product number:
  EMEA/H/C/006370
• 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 applicant:
  Regeneron Ireland Designated Activity Company (DAC)
• Opinion adopted:
  27/02/2025
• Opinion status:
  Positive