BEXLUTRY (lutetium lu-177 dotatate) · CURIUM
BEXLUTRY is FDA-approved to treat 1 condition (same as LUTATHERA).
Details
- Status
- Prescription
- First Approved
- 2026-09-14
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
BEXLUTRY Approval History
What BEXLUTRY Treats
1 indicationsBEXLUTRY is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroenteropancreatic Neuroendocrine Tumors
Same approved indications as LUTATHERA (same active ingredient).
CURIUM's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
BEXLUTRY FDA Label Details
Indications & Usage
FDA Label (PDF)BEXLUTRY is FDA-approved to treat 1 condition — same approved indications as LUTATHERA.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.