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
Mechanism of action Bcl-2 inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration November 2023
Orphan drug Yes
Registration phase Clinical trials
Additional comments fase 3, in combinatie met ruxolitinib (doel verkleinen van lever).

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 comments 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 ~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 naïve 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.