Extended indication Aglatimagene besadenovec in combination with valacyclovir, radiation therapy and optional androgen d
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Aglatimagene besadenovec
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Aglatimagene besadenovec in combination with valacyclovir, radiation therapy and optional androgen deprivation therapy for first line treatment of intermediate-high risk localized Prostate cancer in male adults and elderly
Manufacturer Candel
Route of administration Rectal
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Aglatimagene besadenovec (CAN-2409) is an adenoviral replication-defective engineered gene construct encoding the thymidine kinase gene derived from the herpes simplex virus (HSV).

Registration

Registration route Centralised (EMA)
ATMP Yes
Submission date March 2025
Expected Registration April 2026
Orphan drug Yes
Registration phase Clinical trials
Additional remarks Potentieel ATMP Fast track FDA.

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen resultaten uit de fase 3 studie bekend.
References NCT01436968
Additional remarks Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. The third injection will be 15-22 days after the 2nd injection.

Expected patient volume per year

References (1) IKNL 2022
Additional remarks In 2022 waren er 12.400 patiënten met prostaatkanker (1).

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.