IDAMYCIN PFS (idarubicin hydrochloride)
Idamycin PFS helps adult patients with acute myeloid leukemia (AML). It is used as one part of a larger combination chemotherapy plan to manage this condition. This medication belongs to the anthracycline class and is prescribed to help stop the growth of leukemia cells.
How IDAMYCIN PFS Works
This drug works by binding directly to DNA to form complexes that prevent the body from making new nucleic acids. It also blocks the activity of topoisomerase II and creates free radicals that damage the DNA of cancer cells. These actions combined prevent cells from dividing and lead to cell death.
Details
- Status
- Prescription
- First Approved
- 1997-02-17
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
IDAMYCIN PFS Approval History
What IDAMYCIN PFS Treats
1 indicationsIDAMYCIN PFS is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Myeloid Leukemia
IDAMYCIN PFS Boxed Warning
CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment [see Warnings and Precautions (5.1) ] ....
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received prior anthracyclines or who have pre-existing cardiac disease. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately terminate the infusion of IDAMYCIN PFS and institute the recommended management procedures [see Dosage and Administration (2.6) and Warnings and Precautions (5.3) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage leading to congestive heart failure can occur with IDAMYCIN PFS. Assess left ventricular cardiac function prior to initiation of IDAMYCIN PFS and during and after treatment. (5.1) • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including IDAMYCIN PFS. (5.2) • Extravasation of IDAMYCIN PFS during administration can result in local tissue injury and necrosis. Immediately discontinue the IDAMYCIN PFS infusion if extravasation occurs. ( 2.6 , 5.3 )
IDAMYCIN PFS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IDAMYCIN PFS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IDAMYCIN PFS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IDAMYCIN PFS
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05955261 | AML23 NCI-2023-04138 | Ph 2 | suspended | A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia |
| NCT04214249 results posted | NCI-2019-08626 NCI-2019-08626, 2000028858 | Ph 2 | active not recruiting | BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia |
| NCT04190550 | NCI-2019-08137 NCI-2019-08137, PHI-115 | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia |
| NCT06316960 | AVACBFKIT | Ph 2 | recruiting | Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation |
| NCT06221683 GMCAII | GMCAII | Ph 2 | recruiting | Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML |
| NCT02029950 | NCI-2013-02426 NCI-2013-02426, J13128 | Ph 1 | completed | Pomalidomide After Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IDAMYCIN PFS FDA Label Details
Indications & Usage
FDA Label (PDF)IDAMYCIN PFS is indicated for the treatment of Acute Myeloid Leukemia.
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, and EXTRAVASATION AND TISSUE NECROSIS • Cardiomyopathy: IDAMYCIN PFS can cause myocardial damage, including acute left ventricular failure, during or after termination of therapy. The risk of cardiomyopathy is increased in patients who have received p...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.