KYXATA
Details
- Status
- Prescription
- First Approved
- 2025-08-08
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
KYXATA Approval History
What KYXATA Treats
1 indicationsKYXATA is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ovarian Carcinoma
KYXATA Boxed Warning
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity...
WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. ( 5.1 ) Immediately withhold KYXATA for severe hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction. ( 5.1 )
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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.
KYXATA FDA Label Details
ProIndications & Usage
FDA Label (PDF)KYXATA is a platinum-based drug indicated in adults: As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma. As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy. 1.1 Initial Treatment of Advanced Ovarian Carcinoma KYXATA, as part of a combination regimen, is indicated for the initial treatment of adults with advanced ovarian carcinoma. 1.2 Recurrent Advanced Ovarian Carcinoma KYXATA is indicated for treatment of adults with ovarian carcinoma recurrent after prior chemotherapy.
WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS Serious and life-threatening hypersensitivity reactions, including anaphylaxis, can occur with KYXATA within minutes of administration during any cycle. Immediately discontinue KYXATA for severe hypersensitivity reactions and administer appr...
KYXATA Patents & Exclusivity
Patents (9 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.