Talazoparib

Active substance Talazoparib
Domain Oncology and Hematology
Main indication Breast cancer
Extended indication Advanced breast cancer, BRCA mutation-positive - 2nd or 3rd-line.

Product

Manufacturer Pfizer
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Poly(ADP-ribose) polymerase (PARP) inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date June 2018
Expected Registration May 2019
Orphan drug No
Registration phase Registration application pending
Additional comments Fase III studie (NCT01945775, EMBRACA : PFS extended).

Therapeutic value

Current treatment options Capecitabine, Eribulin, Gemcitabine or Vinorelbine
Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times a day
Dosage per administration 1 mg
References NCT01945775

Expected patient volume per year

Patient volume

< 207

Market share is generally not included unless otherwise stated.

References NKR, clinicaltrials.gov, SPS
Additional comments Borstkanker stadium 3 en 4, excl. HER2+ (zie criteria studie clinicaltrials.gov) betreft 2068 (bron NKR), SPS geeft aan dat BRCA1 en BRCA2 bij 5-10% van alle borstkankers voorkomt. Bij het maximum zijn we uitgegaan van 10% wat zorgt voor een maximum volume van 207 patiënten. Zal moeten concurreren met andere PARP-remmers.

Expected cost per patient per year

Cost 60,000.00 - 70,000.00
References Medicijnkosten.nl
Additional comments Zal de concurrentie aan moeten gaan met meerdere andere PARP-remmers zoals olaparib, veliparib en rucaparib. Een behandeling van een jaar met olaparib kost tussen de €60.000 en €70.000. De verwachting is dat Talazoparib in dezelfde prijsrange zal vallen.

Potential total cost per year

Total cost

13,455,000

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Squamous Cell Lung Carcinoma
References clinicaltrials.gov

Other information

There is currently no futher information available.