Extended indication Refractory follicular lymphoma (FL)
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Mosunetuzumab
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Refractory follicular lymphoma (FL)
Manufacturer Genentech
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulant.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity Unknown
ATMP Unknown
Submission date November 2021
Expected Registration July 2022
Orphan drug Unknown
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

Frequency of administration 1 times every 4 weeks
References NCT04712097
Additional remarks Patients will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information