pegfilgrastim

Active substance
pegfilgrastim
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Hematology other
Extended indication
In combination with plinabulin in patients with chemotherapy-induced neutropenia.

1. Product

Manufacturer
Beyondspring
Mechanism of action
Other
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Guanine nucleotide exchange factor stimulant

2. Registration

Registration route
Centralised (EMA)
Submission date
June 2020
Expected Registration
July 2021
Registration phase
Registration application pending

3. Therapeutic value

Current treatment options
Pegfilgrastim
Therapeutic value
No judgement
Duration of treatment
Average 12 week / weeks
Frequency of administration
1 times every 3 weeks
Dosage per administration
40 mg
References
NCT03294577

4. Expected patient volume per year

There is currently nothing known about the expected patient volume.

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
Non-small cell lung cancer
References
clincaltrials.gov
Additional comments
Lopende fase 3 studie

9. Other information

There is currently no futher information available.