Extended indication In combination with plinabulin in patients with chemotherapy-induced neutropenia.
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance pegfilgrastim
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Other hematology
Extended indication In combination with plinabulin in patients with chemotherapy-induced neutropenia.
Manufacturer Beyondspring
Mechanism of action Other
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Guanine nucleotide exchange factor stimulant

Registration

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

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

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 Yes
Indication extensions Non-small cell lung cancer
References clincaltrials.gov
Additional remarks Lopende fase 3 studie

Other information

There is currently no futher information available.