Breyanzi
Breyanzi, Suspension
Breyanzi is a medicine with orphan drug status in Switzerland, active substance lisocabtagenum maraleucelum, authorisation holder Bristol-Myers Squibb SA. Swissmedic publishes 6 orphan indications for this product.
The medicine is authorised under number 67469, first authorised on 28/03/2022.
Data
Data from the Swissmedic list of medicinal products with orphan drug status (Art. 7 TPLO), as of 2026-09-18. Swissmedic updates the list every month.
| Active substances | lisocabtagenum maraleucelum |
|---|---|
| Authorisation holder | Bristol-Myers Squibb SA |
| Authorisation number | 67469 |
| Authorisation status | Authorised |
| First authorised | 28/03/2022 |
| Temporary until | - |
| Authorised indication | Breyanzi ist indiziert zur Behandlung von erwachsenen Patienten mit • diffusem grosszelligem B-Zell-Lymphom (DLBCL), High-Grade-B-Zell Lymphom (HGBCL) oder primär mediastinalem grosszelligem B-Zell-Lymphom (PMBCL), das auf die Erstlinien-Chemoimmuntherapie refraktär ist oder innerhalb von 12 Monaten nach der Erstlinien-Chemoimmuntherapie rezidiviert • rezidiviertem oder refraktärem (r/r) DLBCL, HGBCL oder PMBCL nach zwei oder mehr systemischen Therapielinien • rezidiviertem oder refraktärem (r/r) follikulärem Lymphom (FL) nach zwei oder mehr systemischen Therapielinien • rezidiviertem oder refraktärem (r/r) Mantelzell-Lymphom (MCL) nach mindestens zwei systemischen Therapielinien, einschliesslich eines Bruton-Tyrosinkinase (BTK)-Inhibitors |
Orphan designations
Swissmedic publishes one row per medicine and orphan indication: the indication in the wording of the decision, the date the status was granted and, where the status was withdrawn, the withdrawal date. The table below reproduces those rows unchanged and links every indication to the matching rare disease in the directory.
| Orphan indication | Disease | Status granted | Status withdrawn |
|---|---|---|---|
| Mantelzelllymphom (MCL) | Mantle cell lymphoma | 30/07/2024 | Status active |
| Chronisch Lymphatische Leukämie (CLL) | Chronic lymphocytic leukaemia (CLL) | 25/01/2024 | Status active |
| Hochmalignes B-Zell Lymphom | High-grade B-cell lymphoma | 08/09/2022 | Status active |
| Follikuläres Lymphom | Follicular lymphoma | 14/05/2020 | Status active |
| Primär Mediastinales Grosszelliges B-Zell-Lymphom | Diffuse large B-cell lymphoma (DLBCL) | 05/02/2020 | Status active |
| Diffuses grosszelliges B-Zell-Lymphom (DLBCL) | Diffuse large B-cell lymphoma (DLBCL) | 06/06/2019 | Status active |
Reimbursement
Whether compulsory health insurance pays for this medicine depends on the FOPH specialities list (SL). Medicines that are not listed can be reimbursed case by case under Art. 71a-71d KVV.
Frequently asked questions
Is Breyanzi authorised in Switzerland?
Yes. Breyanzi is authorised by Swissmedic under number 67469, first authorised on 28/03/2022. The product also carries orphan drug status for a rare disease.
What does orphan drug status mean for Breyanzi?
The status opens the simplified authorisation procedure (Art. 14 para. 1 let. f TPA), priority assessment, a waiver of the flat-rate fee for the new authorisation application (Art. 9 let. a FeeO-Swissmedic) and, on request, 15 years of document protection (Art. 11b para. 4 TPA).
Is Breyanzi reimbursed by Swiss health insurance?
That depends on the FOPH specialities list (SL), not on the orphan drug status. If the product is not listed, reimbursement in an individual case under Art. 71a to 71d KVV can apply. Check the current SL entry and public price in the FOPH specialities list.
Medicines
Bring your orphan drug to Switzerland
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
- Public Swissmedic data
- Four language versions