Aglatimagene besadenovec Medicine 04 June 2024 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 Total cost 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 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Candel Portfolio holder Mechanism of action Unknown Route of administration Rectal Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise 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) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date March 2025 Expected Registration April 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Potentieel ATMP Fast track FDA. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten uit de fase 3 studie bekend. Duration of treatment Frequency of administration Dosage per administration 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 Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References (1) IKNL 2022 Additional remarks In 2022 waren er 12.400 patiënten met prostaatkanker (1). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks