Extended indication

In Combination With Oral Ruxolitinib (Myelofibrosis)

Therapeutic value

No estimate possible yet

Registration phase

Clinical trials

Product

Active substance

Navitoclax

Domain

Hematology

Reason of inclusion

New medicine (specialité)

Main indication

Myeloproliferative disorders

Extended indication

In Combination With Oral Ruxolitinib (Myelofibrosis)

Manufacturer

Abbvie

Portfolio holder

Abbvie

Mechanism of action

Bcl-2 inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Submission date

September 2023

Expected Registration

September 2024

Orphan drug

Yes

Registration phase

Clinical trials

Additional remarks
Fase 3, in combinatie met ruxolitinib (doel verkleinen van lever). Fabrikant geeft aan registratie te verwachten in september 2024.

Therapeutic value

Therapeutic value

No estimate possible yet

References
NCT04472598 (TRANSFORM-1); NCT04468984 (TRANSFORM-2);

Expected patient volume per year

Patient volume

120

Market share is generally not included unless otherwise stated.

References
NKR; fabrikant; expert opinie.
Additional remarks
Er waren 166 diagnoses van myelofibrosis in 2018. De verwachting is dat de indicatie ook post ruxolitinib behandeling bevat. Van de 166 nieuw gediagnosticeerde patiënten zal uiteindelijk ongeveer 75% (125 patiënten) behandeld worden met ruxolitinib. Enkele patiënten ontvangen geen behandeling. Van deze 125 patiënten die ruxolitinib krijgen zal 80% (100 patiënten) in aanmerking komen voor een vervolg behandeling met navitoclax (fit for treatment) (2L; post ruxolitinib). Per jaar komen er 120 patiënten in aanmerking voor de behandeling met navitoclax: 100 post ruxolitinib (2L) en 20 JAKi naïeve patiënten (1L).

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.