Lacutamab

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	December 2024
Expected Registration	September 2025
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	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 remarks	Toediening is gedurende 5 weken iedere week, daarna 10 toedieningen elke twee weken en tenslotte 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 remarks	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.

Patient volume

< 10

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

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.