Extended indication Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the tre
Therapeutic value Possible benefit in ease of use
Registration phase Registered

Product

Active substance Leuprolide mesylate
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.
Proprietary name Camcevi
Manufacturer Foresee
Mechanism of action Receptor agonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments LHRH agonist, ook bekend als FP-001

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date April 2020
Expected Registration April 2022
Orphan drug No
Registration phase Registered
Additional comments Ingediend bij de FDA in maart 2019. Positieve CHMP opinie ontvangen in maart 2022.

Therapeutic value

Current treatment options Leuprolide (kortwerkend)
Therapeutic value Possible benefit in ease of use
Substantiation Het betreft een 6-maands depot versie.
Duration of treatment Average 1 year / years
Frequency of administration 1 times every 6 months
Dosage per administration 50 mg
References NCT02234115; https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-submission-of-nda-for-fda-approval-of-lmis-50-mg-300821225.html

Expected patient volume per year

Additional comments Dit zal met name substitutie betreffen van de huidige kortdurende vorm van leuproreline.

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

Other information

There is currently no futher information available.