DANZITEN
Details
- Status
- Prescription
- First Approved
- 2024-11-07
- Routes
- ORAL
- Dosage Forms
- TABLET
DANZITEN Approval History
What DANZITEN Treats
1 indicationsDANZITEN is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
DANZITEN Boxed Warning
QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ s...
WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ see Warnings and Precautions ( 5.4 ) ]. Do not administer DANZITEN tablets to patients with hypokalemia, hypomagnesemia, or long QT syndrome [ see Contraindications (4), Warnings and Precautions ( 5.3 ) ]. • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [ see Drug Interactions ( 7.1 , 7.2 ) ]. WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. ( 5.3 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.3 , 5.4 , 5.8 , 5.12 ) • Sudden deaths have been reported in patients receiving nilotinib. ( 5.4 ) Do not administer DANZITEN to patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 , 5.3 ) • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2 )
DANZITEN Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
DANZITEN Competitors
Pro4 other drugs also target BCR-ABL. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (BCR-ABL). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
DANZITEN FDA Label Details
ProIndications & Usage
FDA Label (PDF)DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for ...
WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days afte...
DANZITEN Patents & Exclusivity
Patents (12 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.