Difference between revisions of "Sorafenib (Nexavar)"
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*11/16/2007: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129234.htm FDA approved] "for the treatment of patients with unresectable [[Hepatocellular carcinoma| hepatocellular carcinoma (HCC)]]." | *11/16/2007: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129234.htm FDA approved] "for the treatment of patients with unresectable [[Hepatocellular carcinoma| hepatocellular carcinoma (HCC)]]." | ||
*11/22/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376547.htm FDA approved] "for the treatment of locally recurrent or metastatic, progressive, [[Thyroid cancer | differentiated thyroid carcinoma (DTC)]] refractory to radioactive iodine treatment" | *11/22/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376547.htm FDA approved] "for the treatment of locally recurrent or metastatic, progressive, [[Thyroid cancer | differentiated thyroid carcinoma (DTC)]] refractory to radioactive iodine treatment" | ||
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| + | ==History of changes in EMA indication== | ||
| + | *7/19/2006: Initial marketing authorization as Nexavar | ||
==Also known as== | ==Also known as== | ||
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[[Category:Medullary thyroid cancer medications]] | [[Category:Medullary thyroid cancer medications]] | ||
| + | [[Category:EMA approved in 2006]] | ||
[[Category:FDA approved in 2005]] | [[Category:FDA approved in 2005]] | ||
Revision as of 13:12, 4 December 2021
General information
Class/mechanism: Tyrosine kinase inhibitor that inhibits multiple kinases: RAF1, BRAF, KIT, FLT-3, RET, vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, VEGFR-3, and platelet-derived growth factor receptor beta (PDGFR-B). Inhibition of these kinases disrupts angiogenesis, tumor cell signaling, and induces apoptosis.[1][2][3]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- Acute myeloid leukemia
- Hepatocellular carcinoma
- Non-small cell lung cancer
- Osteosarcoma
- Renal cell carcinoma
- Soft tissue sarcoma
- Thyroid cancer
Patient drug information
- Sorafenib (Nexavar) package insert[1]
- Sorafenib (Nexavar) patient drug information (Chemocare)[4]
- Sorafenib (Nexavar) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 12/20/2005: FDA approved "for the treatment of patients with advanced renal cell carcinoma (RCC)."
- 11/16/2007: FDA approved "for the treatment of patients with unresectable hepatocellular carcinoma (HCC)."
- 11/22/2013: FDA approved "for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment"
History of changes in EMA indication
- 7/19/2006: Initial marketing authorization as Nexavar
Also known as
- Code names: BAY 43-9006, BAY 54-9085
- Brand names: Nexavar, Sorafenat, Soranib
References
- Drugs
- Oral medications
- BRAF inhibitors
- FLT3 inhibitors
- KIT inhibitors
- PDGFR inhibitors
- RAF1 inhibitors
- RET inhibitors
- VEGFR inhibitors
- Acute myeloid leukemia medications
- Hepatocellular carcinoma medications
- Non-small cell lung cancer medications
- Osteosarcoma medications
- Renal cell carcinoma medications
- Desmoid tumor medications
- Thyroid cancer medications
- Differentiated thyroid cancer medications
- Medullary thyroid cancer medications
- EMA approved in 2006
- FDA approved in 2005