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Alpelisib

Extended indication Treatment of postmenopausal women, and  men, with hormone receptor positive, HER2-negative, advanced
Therapeutic value No judgement yet
Registration phase Clinical trials

Product

Active substance Alpelisib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Breast cancer
Extended indication Treatment of postmenopausal women, and  men, with hormone receptor positive, HER2-negative, advanced breast cancer with PIK3CA mutation in combination with fulvestrant after disease progression following an endocrine-based regimen.ant
Manufacturer Novartis
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks α-specifieke class I phosphatidylinositol-3-kinase (PI3K) remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2019
Expected Registration April 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Diverse waaronder everolimus, palbociclib, letrozol, fulvestrant etc.
Therapeutic value No judgement yet
Substantiation De SOLAR-1 studie laat langere PFS zien ten opzichte van placebo.
Frequency of administration 1 times a day
Dosage per administration 300 mg
References NCT02437318 (SOLAR-1); ESMO Abstract LBA3_PR
Additional remarks SOLAR-1: "Alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)". Verwachte mediane behandelduur is minder dan 1 jaar

Expected patient volume per year

Patient volume

< 300

Market share is generally not included unless otherwise stated.
References Fabrikant; ZiN Pakketadvies palbociclib, 11 april 2017; Mukohara. Breast Cancer (Dove Med Press). 2015 May 15;7:111-23.
Additional remarks Van de naar schatting 1.700 patiënten in 1e lijn, krijgt naar verwachting 70% (=1.190 patiënten) een behandeling in 2e lijn. Circa 30% hiervan heeft een PIK3CA mutatie en komt daarmee theoretisch in aanmerking voor alpelisib. Het verwachte patiëntenvolume ligt maximaal rond de 300. De vraag is wel of alle patiënten getest gaan worden voor deze mutatie en of ze in dat geval niet met een CDK4/6 remmer behandeld zullen worden. Om deze reden zal het uiteindelijke patiëntenaantal waarschijnlijk lager liggen dan 300.

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

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.