COSMEGEN

LOE Approaching

dactinomycin

Recordati
NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1

Mechanism of Action

synthesis. The cytotoxic activity of dactinomycin has been demonstrated in animal models of different human cancers.

Indications (9)

part of a multi-phasecombination chemotherapy regimennonseminomatous testicular cancerpost-menarchal patients with gestational trophoblastic neoplasiaa single agentpart of a combination chemotherapy regimenlocoregional solid malignanciesa component of palliativeadjunctive regional perfusion

Clinical Trials (1)

NCT01323517Phase 2Completed

Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity

Started Feb 2011
26 enrolled
Melanoma
Company
Recordati
Recordati
France - Saint-Victor
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers