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EMA Product

Jaypirca

Product approved by European Medicines Agency (EU)

Basic Information

Jaypirca

Regulatory Information

EMEA/H/C/005863

Authorised

October 30, 2023

April 26, 2023

2

November 20, 2023

Company Information

Netherlands

Papendorpseweg 83 3528 BJ Utrecht

Eli Lilly Nederland BV

Drug Classification

Conditional ApprovalAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Treatment of mantle cell lymphoma (MCL)

Overview Summary

Jaypirca is a cancer medicine used to treat adults with mantle cell lymphoma (a cancer of B cells, a type of white blood cell) whose cancer has come back (relapsed) or no longer responds to treatment (refractory), and who had previously received a type of cancer medicine called a Bruton’s tyrosine kinase (BTK) inhibitor. Mantle cell lymphoma is rare, and Jaypirca was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21 June 2021. Further information on the orphan designation can be found on the EMA [website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2450). Jaypirca contains the active substance pirtobrutinib.

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