Lisocabtagene maraleucel

Extended indication	Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory follicular lymphoma in adults and elderly who have received 2 or more prior lines of systemic therapy
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Lisocabtagene maraleucel
Domain	Hematology
Reason of inclusion	Indication extension
Main indication	Indolent non-Hodgkin’s lymphoma
Extended indication	Lisocabtagene maraleucel monotherapy for third line or later treatment of relapsed or refractory follicular lymphoma in adults and elderly who have received 2 or more prior lines of systemic therapy
Proprietary name	Breyanzi
Manufacturer	BMS
Portfolio holder	BMS
Mechanism of action	CAR-T therapy
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	Yes
Submission date	August 2024
Expected Registration	March 2025
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Verwachte registratie op basis van IHSI-inschatting.

Current treatment options	De huidige standaardbehandeling voor patiënten met FL met een recidief na eerstelijns behandeling bestaat uit een aantal immunochemotherapie opties, radiotherapie of radio-labeled antilichaam, rituximab monotherapie of in combinatie met lenalidomide, en idelalisib (in rituximab refractaire patiënten). In de derde of latere lijns behandeling kunnen dezelfde opties gebruikt worden voor zover deze nog niet gebruikt zijn, of kan er gekozen worden voor een op PECC (etoposide, chlorambucil, lomustine, prednisolon) of DHAP (dexamethason, cisplatin, cytarabine) gebaseerd chemotherapie schema. De behandelkeuze hangt af van de eerder gegeven behandelingen en de responsduur.
Therapeutic value	No estimate possible yet
Duration of treatment	one-off
References	NCT04245839 (TRANSCEND FL)
Additional remarks	For follicular lymphoma (FL), the dose is 90 to 110 x 10^6 CAR-positive viable T cells. A single dose of BREYANZI consists of 1:1 CAR-positive viable T cells of the CD8 and CD4 components, with each component supplied separately in one to four single-dose 5 mL vials. Each mL contains ≥1.5 × 10^6 to 70 × 10^6 CAR-positive viable T cells.

There is currently nothing known about the expected patient volume.

Cost	345,000.00
References	Zorginstituut Nederland. Advies - vergoed lisocabtagene maraleucel (Breyanzi®) voor de behandeling van lymfeklierkanker. 2024.
Additional remarks	De AIP van liso-cel is € 345.000. Dit geneesmiddel is breed in de sluis geplaatst.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.