Jaypirca - opinion on variation to marketing authorisation

Opinion

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

pirtobrutinib

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 Jaypirca. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted a new indication as follows:

Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).

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

Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.

Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).

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-authoirsation summary of positive opinion for Jaypirca (VR-0000316267)

Adopted Reference Number: EMADOC-1700519818-3256196

Key facts

• Name of medicine:
  Jaypirca
• EMA product number:
  EMEA/H/C/005863
• Active substance:
  pirtobrutinib
• International non-proprietary name (INN) or common name:
  pirtobrutinib
• Therapeutic area (MeSH):
  Lymphoma, Mantle-Cell
• Anatomical therapeutical chemical (ATC) code:
  L01
• 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:
  Eli Lilly Nederland B.V.
• Date of opinion:
  25/06/2026
• Status:
  Positive