# Pirtobrutinib

Pirtobrutinib (Jaypirca, Eli Lilly Nederland B.V.) has 2 EU-approved indications in 2 tumour types.

## Approved indications

### Chronic lymphocytic leukaemia

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | - |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor |

## Products

### Jaypirca

- Company: Eli Lilly Nederland B.V.
- Target: Noncovalent BTK inhibitor
- Class: Antineoplastic agents
- ATC: L01
- EU approval: 30 Oct 2023
- Label revised: 15 Sep 2026
- Status: conditional approval
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/jaypirca-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/jaypirca

Mechanism (SmPC section 5.1): Pirtobrutinib reversibly binds wild-type and C481-mutant BTK, inhibiting its kinase activity to block BCR-mediated B-cell proliferation, trafficking, and survival pathways.

## Label wording

- **Pirtobrutinib** (Jaypirca), Mantle cell lymphoma, 2nd line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf)
- **Pirtobrutinib** (Jaypirca), Chronic lymphocytic leukaemia, any line: “Jaypirca as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jaypirca-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/pirtobrutinib