Extended indication Treatment of patients with Sézary Syndrome who have received at least two prior systemic therapies.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Lacutamab
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication Indolent non-Hodgkin’s lymphoma
Extended indication Treatment of patients with Sézary Syndrome who have received at least two prior systemic therapies.
Manufacturer Innate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
ATMP No
Submission date 2022
Expected Registration 2023
Orphan drug Yes
Registration phase Clinical trials
Additional comments PRIME designation sinds november 2020. Primary completion date fase 2 TELLOMAK studie in maart 2022.

Therapeutic value

Current treatment options Systemische chemotherapie, mogamulizumab
Therapeutic value No estimate possible yet
References NCT03902184
Additional comments Toediening is gedurende 5 weken iedere week, daarna 10 toedieningen elke twee weken en ten slotte elke 4 weken tot progressie of toxiciteit.

Expected patient volume per year

Patient volume

< 10

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Incidentie CTCL in 2016 (NKR): 131. Expertopinie schat het aantal patiënten per jaar in op minder dan 10. De patiënt heeft eerst twee andere systemische behandeling ontvangen, een klein gedeelte zal dit overleven.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Mycosis fungoides; Peripheral T-cell lymphoma; Cutaneous T-cell lymphoma
References Adis Insight

Other information

There is currently no futher information available.