Pirtobrutinib

Pirtobrutinib (Jaypirca, Eli Lilly Nederland B.V.) has 2 EU-approved indications in 2 tumour types.
Approved indications of Pirtobrutinib
Biomarker requirementRegimenSettingConditions
Chronic lymphocytic leukaemia1
None
Monotherapy
Any line
None
Mantle cell lymphoma1
None
Monotherapy
2L
Previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor
Full text of section 4.1 (therapeutic indications)

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).

Label history

6 changes to the Jaypirca label since 2024, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes