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.