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Selpercatinib

Retsevmo

Extended indication

2L+tumour agnostic–RET positive, no other satisfactory options
Therapeutic value

No estimate possible yet
Registration phase

Clinical trials

Product

Active substance

Selpercatinib
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Tumour agnostic medication
Extended indication

2L+tumour agnostic–RET positive, no other satisfactory options
Proprietary name

Retsevmo
Manufacturer

Eli Lilly
Portfolio holder

Eli Lilly
Mechanism of action

Tyrosine kinase inhibitor
Route of administration

Oral
Therapeutical formulation

Capsule
Budgetting framework

Intermural (MSZ)
Additional comments 
Selpercatinib is een remmer van de rearranged during transfection (RET)-receptor tyrosinekinase.

Registration

Registration route

Centralised (EMA)
ATMP

No
Submission date

2023
Expected Registration

2023
Orphan drug

No
Registration phase

Clinical trials

Therapeutic value

Current treatment options

Geen
Therapeutic value

No estimate possible yet
Duration of treatment

Median 13.2 month / months
Frequency of administration

2 times a day
Dosage per administration

160mg
References 
SmPC; 
Meeting Abstract | 2022 ASCO Annual Meeting.
Additional comments 
ORR: 44%
mPFS: 13,2 maanden

Expected patient volume per year

References 
American Association for Cancer Research (AACR) Project GENIE cBioPortal for Cancer Genomics.
AACR Project GENIE Consortium. AACR Project GENIE: powering precision medicine through an International Consortium. Cancer Discov. 2017;7(8):818-831.
Additional comments 
In LIBRETTO-001 waren de meest voorkomende tumoren anders dan long- of schildkliertumoren: pancreas, colorectaal, onbekend primair en cholangiocarcinoom. Dit komt grotendeels overeen met de voorspelde incidentiecijfers.
Incidentie: Pancreas (0,08%), colorectaal (0,26%), onbekend primair (0,36%), cholangiocarcinoom (0,17%). het verwachte percentage van RET-incidenties in andere tumoren dan long en schildklier is 0,24%.

Expected cost per patient per year

Cost

€ 129,210.00
References 
Z-index juli 2022

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

Indication extension

Yes
Indication extensions

zie overige indicaties op de scan, ook lopende studies CNS kanker
References 
AdisInsight

Other information

There is currently no futher information available.