Extended indication Multiple myeloma (MM), relapsed/refractory, in patients who have received bortezomib and lenalidomid
Therapeutic value No judgement
Registration phase Negative CHMP opinion

Product

Active substance Plitidepsin
Domain Oncology and Hematology
Main indication Multiple Myeloma
Extended indication Multiple myeloma (MM), relapsed/refractory, in patients who have received bortezomib and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available).
Proprietary name Aplidin
Manufacturer Pharma Mar
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date November 2016
Orphan drug Yes
Registration phase Negative CHMP opinion
Additional remarks Negatieve opinie CHMP december 2017. Fabrikant heeft een herbeoordeling aangevraagd. Opnieuw negatieve opinie CHMP maart 2018.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

Patient volume

135

Market share is generally not included unless otherwise stated.

References Budget impact analyse van daratumumab (Darzalex) in combinatie met lenalidomide en dexamethason voor de indicatie volwassen patiënten met multipel myeloom die minstens één eerdere behandeling hebben gehad.
Additional remarks NKR (2015): 1.242 patiënten met MM (maximaal). Gezien relapsed / refractory en overige behandelingen zal het realistische volume echter een stuk lager liggen. Voor Daratumumab is het verwachte aantal patiënten dat in 2018 in aanmerking komt voor behandeling 135.

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.