AFINITOR DISPERZ
Everolimus is a kinase inhibitor with distinct indications based on formulation. It is indicated for the treatment of postmenopausal women with advanced HR+, HER2- breast cancer **in combination with exemestane** after failure of letrozole or anastrozole. It is also used for adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of pancreatic, gastrointestinal, or lung origin that are unresectable, locally advanced, or metastatic (not indicated for functional carcinoid tumors). Additionally, it is indicated for adults with advanced renal cell carcinoma (RCC) after failure of sunitinib or sorafenib. Regarding Tuberous Sclerosis Complex (TSC), everolimus is indicated for: * Adults with renal angiomyolipoma not requiring immediate surgery. * Adult and pediatric patients (aged 1 year and older) with subependymal giant cell astrocytoma (SEGA) requiring intervention but not amenable to curative resection. * **Adjunctive** treatment of adult and pediatric patients (aged 2 years and older) with TSC-associated partial-onset seizures.
How AFINITOR DISPERZ Works
Everolimus is an inhibitor of the mammalian target of rapamycin (mTOR), specifically targeting the mTORC1 complex. It acts as a downstream effector of the PI3
Details
- Status
- Prescription
- First Approved
- 2012-08-29
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
AFINITOR DISPERZ Approval History
What AFINITOR DISPERZ Treats
7 indicationsAFINITOR DISPERZ is approved for 7 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Neuroendocrine Tumors
- Renal Cell Carcinoma
- Renal Angiomyolipoma
- Tuberous Sclerosis Complex
- Subependymal Giant Cell Astrocytoma
- Partial-Onset Seizures
AFINITOR DISPERZ Competitors
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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.
AFINITOR DISPERZ FDA Label Details
ProIndications & Usage
FDA Label (PDF)Everolimus tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: Everolimus tablets are not indicated for the treatment of patient...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.