Dactinomycin

Overview

A compound composed of a two cyclic peptides attached to a phenoxazine that is derived from streptomyces parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015)

Indication

For the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer as part of a combination chemotherapy and/or multi-modality treatment regimen

Associated Conditions

Ewing's Sarcoma
Gestational Trophoblastic Neoplasia
Osteosarcoma
Ovarian Cancer
Rhabdomyosarcomas
Wilms' tumor
Metastatic nonseminomatous Testicular cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma	2024/10/18	NCT06647953	Phase 3	Recruiting	Children's Oncology Group
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)	2024/05/06	NCT06401330	Phase 3	Recruiting	Children's Oncology Group
GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)	2024/03/13	NCT06309732	Phase 2	Completed	Queen Mary University of London
Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6	2023/09/08	NCT06028672	Not Applicable	Recruiting	Peking Union Medical College Hospital
Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease	2023/09/05	NCT06023641	Phase 2	Recruiting	St. Jude Children's Research Hospital
Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7	2023/09/01	NCT06020755	Phase 2	Recruiting	Peking Union Medical College Hospital
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma	2022/03/31	NCT05304585	Phase 3	Recruiting	Children's Oncology Group
A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma	2021/08/06	NCT04994132	Phase 3	Active, not recruiting	Children's Oncology Group
FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma	2020/11/12	NCT04625907	Phase 1	Recruiting	University of Birmingham
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia	2020/09/24	NCT04562558	Not Applicable	Active, not recruiting	xiang yang

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
dactinomycin	XGen Pharmaceuticals DJB, Inc.	39822-2100	INTRAVENOUS	0.5 mg in 1 mL	2/23/2021
DACTINOMYCIN	Eugia US LLC	55150-431	INTRAVENOUS	0.5 mg in 1 mL	12/20/2023
Dactinomycin	Hisun Pharmaceuticals USA, Inc.	42658-008	INTRAVENOUS	0.5 mg in 1 1	9/17/2020
Dactinomycin	Prasco Laboratories	66993-489	INTRAVENOUS	0.5 mg in 1 mL	1/18/2024
Cosmegen	Recordati Rare Diseases, Inc.	55292-811	INTRAVENOUS	0.5 mg in 1 mL	1/18/2024
Dactinomycin	Meitheal Pharmaceuticals Inc.	71288-129	INTRAVENOUS	0.5 mg in 1 mL	8/31/2020
DACTINOMYCIN	AuroMedics Pharma LLC	55150-928	INTRAVENOUS	0.5 mg in 1 mL	8/11/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
K. U. DACTINOMYCIN FOR INJECTION 0.5 mg/vial	KOREA UNITED PHARMACEUTICAL INC	SIN10989P	INJECTION, POWDER, FOR SOLUTION	0.5 mg/vial	6/25/1999

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Cosmegen dactinomycin (actinomycin D) 0.5mg injection	10463	Recordati Rare Diseases Australia Pty Ltd	Medicine	A	7/22/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
COSMEGEN	recordati rare diseases canada inc	00213071	Powder For Solution - Intravenous	0.5 MG / VIAL	12/31/1963

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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