Surufatinib

Active substance
Surufatinib
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Neuroendocrine cancer
Extended indication
Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors.

1. Product

Manufacturer
Hutchison MediPharma
Mechanism of action
Angiogenesis inhibitor
Route of administration
Oral
Budgetting framework
Intermural (MSZ)
Additional comments
Surufatinib inhibits tyrosine kinase activity associated with VEGFR and FGFR. Grade 1 (low-grade tumor): These cells divide at a low rate and therefore grow slowly. Grade 2 (intermediate-grade tumor): These cells divide at an intermediate rate.

2. Registration

Registration route
Centralised (EMA)
Submission date
2021
Expected Registration
2022
Orphan drug
Yes
Registration phase
Clinical trials
Additional comments
Fabrikant heeft aangegeven registratie bij de FDA te plannen, wanneer indiening bij de EMA plaats zal vinden is nog niet bekend.

3. Therapeutic value

Current treatment options
Huidige behandelopties zijn beperkt, met name chirurgie.
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
1 times every 4 weeks
Dosage per administration
300 mg
References
NCT02588170

4. Expected patient volume per year

References
NKR
Additional comments
Jaarlijks krijgen in Nederland ruim 700 mensen een neuroendocriene tumor. 9% van alle neuro-endocriene tumoren ontstaan in de pancreas. Het patiëntaantal voor deze indicatie zal beperkt zijn. Bij komende indicatie-uitbreidingen zullen grotere patiëntvolumes gemoeid zijn.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Overige Neuro Endocriene Tumoren en Biliary cancer.
References
clinicaltrials.gov; adisinsight
Additional comments
Lopende fase 3 studies.

9. Other information

There is currently no futher information available.