Aglatimagene besadenovec

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
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 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	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.

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

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.