Pirtobrutinib (1) – Jaypirca®
Mantle cell lymphoma, pre-treated patients
Characteristics
| Start date | 15.02.2025 – Marketing authorisation: 30.10.2023 |
|---|---|
| Resolution | 07.08.2025 |
| INN | Pirtobrutinib |
| Brand name | Jaypirca® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-1164 |
| ATC code | L01EL05 BTK inhibitors (L01EL) |
| ICD-10 codes (AIS) | C83.1Centrocytic lymphoma |
| Alpha-ID codes (AIS) | I111242Mantle cell lymphoma |
| Therapeutic area | Oncological diseases Mantle cell lymphoma (MCL) |
| Reason for procedure | Initial assessment |
| Regulatory status | Conditional Approval |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
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Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously been treated with a Bruton's tyrosine kinase (BTK) inhibitor. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with relapsed or refractory mantle cell lymphoma who have received at least one prior therapy with a Bruton's tyrosine kinase (BTK) inhibitor | Individualised therapy with selection of – Bendamustine + rituximab, – lenalidomide ± rituximab, – R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), – VRCAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, prednisone), – R-BAC (rituximab + bendamustine + cytarabine), – R-FCM (fludarabine + cyclophosphamide + mitoxantrone + rituximab), – ibrutinib, – temsirolimus, – Brexucabtagen autoleucel (only for patients with at least two prior therapies), – venetoclax, – high-dose therapy with allogeneic stem cell transplantation and – High-dose therapy with autologous stem cell transplantation |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (BRUIN) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
| ACT change | 26.09.2023 – Neue Therapiestandards |
- Clinical trials
- For the benefit assessment of pirtobrutinib, the pharmaceutical manufacturer presented the single-arm, ongoing Phase-1/2 trial, BRUIN, to investigate the efficacy, safety and pharmacokinetic properties of pirtobrutinib in adult patients with B-cell neoplasms.
Adults with relapsed or refractory mantle cell lymphoma who have received at least one prior course of treatment with a Bruton’s tyrosine kinase (BTK) inhibitor
- Additional benefit is not proven for pirtobrutinib in the treatment of adults with relapsed or refractory MCL who have previously been treated with a BTK inhibitor.
- As the BRUIN study is a single-arm trial, it does not allow for an assessment of the additional benefit of pirtobrutinib compared with the appropriate comparator therapy and is therefore not suitable for the benefit assessment of pirtobrutinib.
- MAIC analyses compared with aggregated study arms are generally not considered appropriate in the context of benefit assessment.
- Summary of the assessment
- There are therefore no data available that are suitable for a benefit assessment.
- An additional benefit of pirtobrutinib for the treatment of adults with relapsed or refractory MCL who have previously been treated with a BTK inhibitor is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Pirtobrutinib (2) | Jaypirca® | Lilly Deutschland GmbH | Chronic lymphocytic leukaemia (CLL), relapsed or refractory, monotherapy | 5,390–7,490 | 9% Hint for minor additional benefit | |
| Pirtobrutinib (1) | Jaypirca® | Lilly Deutschland GmbH | Mantle cell lymphoma, pre-treated patients | 105–150 | 100% additional benefit not proven |
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