Extended indication Patients With RET-Mutant Medullary Thyroid Cancer
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Selpercatinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Thyroid cancer
Extended indication Patients With RET-Mutant Medullary Thyroid Cancer
Manufacturer Eli Lilly
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Tyrosine kinase inhibitor met antineoplastische eigenschappen. Potente, selectieve remmer van de RET-kinase, ontwikkeld om de ATP-bindingsite vd RET-kinase te blokkeren. Zo wordt de ‘down stream’ signalling pathway geremd.

Registration

Registration route Centralised (EMA)
Submission date February 2020
Expected Registration March 2021
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options RET fusie-positieve NSCLC: Carboplatin/Cisplatin + Pemetrexed +/- Pembrolizumab.RET-gemuteerde medullaire thyroïd kanker: Cabozantinib/vandetanib
Therapeutic value No judgement
Frequency of administration 2 times a day
References NCT04211337 (LIBRETTO-531)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

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

There is currently nothing known about off label use.

Indication extension

Indication extension No
References adisinsight

Other information

There is currently no futher information available.