Carvykti - opinion on variation to marketing authorisation

Opinion

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

ciltacabtagene autoleucel

Opinion

On 22 February 2024, 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 Carvykti. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy. 

For information, the full indications for Carvykti will be as follows:¹

Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least threeone prior therapyies, including an immunomodulatory agent, and a proteasome inhibitor and an anti-CD38 antibody and, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

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

---

¹New text in bold, removed as strikethrough

CHMP post-authorisation summary of positive opinion for Carvykti (II-21)

Reference Number: EMA/CHMP/58610/2024

Key facts

• Name of medicine:
  Carvykti
• EMA product number:
  EMEA/H/C/005095
• Active substance:
  ciltacabtagene autoleucel
• International non-proprietary name (INN) or common name:
  ciltacabtagene autoleucel
• Therapeutic area (MeSH):
  Multiple Myeloma
• Anatomical therapeutical chemical (ATC) code:
  L01XL05
• 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.

• Advanced therapy:

  This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

• 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.

• 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 NV
• Date of opinion:
  22/02/2024
• Status:
  Positive