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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 remarks 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 remarks 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 remarks 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.