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Msg  24907 of 25190  at  7/1/2020 10:29:06 PM  by

alias geo


CABOMETYX (cabozantinib) Off label use

CABOMETYX
(cabozantinib)
RATIONALE FOR INCLUSION IN PA PROGRAM
Background
Cabometyx (cabozantinib) inhibits the tyrosine kinase activity of MET, VEGFR-1, -2, and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment (1).
Regulatory Status
FDA-approved indication: Cabometyx is a kinase inhibitor indicated for the treatment of: (1)
1. Patients with advanced renal cell carcinoma (RCC).
2. Patients with hepatocellular carcinoma (HCC) who have been previously treated with
sorafenib.
Off-Label Use: (2-3)
1. Non-small cell lung cancer
Cabometyx should be used with caution in patients at increased risk for thrombotic events, hemorrhagic events, gastrointestinal perforation and fistulas. Discontinue Cabometyx in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication. Cabometyx should be stopped in patients with a hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. Withhold Cabometyx in patients who develop intolerable Grade 2 or Grade 3 Palmer plantar erthrodysesthesia, until improvement to Grade 1 occurs (1).
Cabometyx should be stopped at least 28 days prior to scheduled surgery, including dental surgery. Permanently discontinue Cabometyx if reversible posterior leukoencephalopathy syndrome (RPLS) occurs. Cabometyx is not recommended for use in patients with severe hepatic impairment (1).
The safety and efficacy of Cabometyx in pediatric patients have not been established (1).
Summary
Cabometyx is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma, Cabometyx FEP Clinical Rationale

CABOMETYX
(cabozantinib)
hepatocellular carcinoma, and has an off-label use for non-small cell lung cancer. Cabometyx should not be used in patients with reversible posterior leukoencephalopathy syndrome (RPLS). Cabometyx should be used with caution in patients at increased risk for thrombotic events, hemorrhagic events, gastrointestinal perforation and fistulas. Cabometyx should be stopped in patients with hypertensive crisis, diarrhea, or palmar-plantar erythrodysethesia syndrome (PPES). The safety and efficacy of Cabometyx in pediatric patients have not been established (1).
Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Cabometyx while maintaining optimal therapeutic outcomes.
References
1. Cabometyx [package insert]. Alameda, CA: Exelixis, Inc.; January 2019.
2. NCCN Drugs & Biologics Compendium® 2019. National Comprehensive Cancer Network, Inc.
January 2019.
3. NCCN Clinical Practice Guidelines in Oncology® Non-Small Cell Lung Cancer (Version 3. 2019).
National Comprehensive Cancer Network, Inc. January 2019.
(cabozantinib)
RATIONALE FOR INCLUSION IN PA PROGRAM
Background
Cabometyx (cabozantinib) inhibits the tyrosine kinase activity of MET, VEGFR-1, -2, and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment (1).
Regulatory Status
FDA-approved indication: Cabometyx is a kinase inhibitor indicated for the treatment of: (1)
1. Patients with advanced renal cell carcinoma (RCC).
2. Patients with hepatocellular carcinoma (HCC) who have been previously treated with
sorafenib.
Off-Label Use: (2-3)
1. Non-small cell lung cancer
Cabometyx should be used with caution in patients at increased risk for thrombotic events, hemorrhagic events, gastrointestinal perforation and fistulas. Discontinue Cabometyx in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication. Cabometyx should be stopped in patients with a hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. Withhold Cabometyx in patients who develop intolerable Grade 2 or Grade 3 Palmer plantar erthrodysesthesia, until improvement to Grade 1 occurs (1).
Cabometyx should be stopped at least 28 days prior to scheduled surgery, including dental surgery. Permanently discontinue Cabometyx if reversible posterior leukoencephalopathy syndrome (RPLS) occurs. Cabometyx is not recommended for use in patients with severe hepatic impairment (1).
The safety and efficacy of Cabometyx in pediatric patients have not been established (1).
Summary
Cabometyx is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma, Cabometyx FEP Clinical Rationale

CABOMETYX
(cabozantinib)
hepatocellular carcinoma, and has an off-label use for non-small cell lung cancer. Cabometyx should not be used in patients with reversible posterior leukoencephalopathy syndrome (RPLS). Cabometyx should be used with caution in patients at increased risk for thrombotic events, hemorrhagic events, gastrointestinal perforation and fistulas. Cabometyx should be stopped in patients with hypertensive crisis, diarrhea, or palmar-plantar erythrodysethesia syndrome (PPES). The safety and efficacy of Cabometyx in pediatric patients have not been established (1).
Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Cabometyx while maintaining optimal therapeutic outcomes.
References
1. Cabometyx [package insert]. Alameda, CA: Exelixis, Inc.; January 2019.
2. NCCN Drugs & Biologics Compendium® 2019. National Comprehensive Cancer Network, Inc.
January 2019.
3. NCCN Clinical Practice Guidelines in Oncology® Non-Small Cell Lung Cancer (Version 3. 2019).
National Comprehensive Cancer Network, Inc. January 2019.
(cabozantinib)
RATIONALE FOR INCLUSION IN PA PROGRAM
Background
Cabometyx (cabozantinib) inhibits the tyrosine kinase activity of MET, VEGFR-1, -2, and -3, AXL, RET, ROS1, TYRO3, MER, KIT, TRKB, FLT-3, and TIE-2. These receptor tyrosine kinases are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, drug resistance, and maintenance of the tumor microenvironment (1).
Regulatory Status
FDA-approved indication: Cabometyx is a kinase inhibitor indicated for the treatment of: (1)
1. Patients with advanced renal cell carcinoma (RCC).
2. Patients with hepatocellular carcinoma (HCC) who have been previously treated with
sorafenib.
Off-Label Use: (2-3)
1. Non-small cell lung cancer
Cabometyx should be used with caution in patients at increased risk for thrombotic events, hemorrhagic events, gastrointestinal perforation and fistulas. Discontinue Cabometyx in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication. Cabometyx should be stopped in patients with a hypertensive crisis or severe hypertension that cannot be controlled with anti-hypertensive therapy. Withhold Cabometyx in patients who develop intolerable Grade 2 or Grade 3 Palmer plantar erthrodysesthesia, until improvement to Grade 1 occurs (1).
Cabometyx should be stopped at least 28 days prior to scheduled surgery, including dental surgery. Permanently discontinue Cabometyx if reversible posterior leukoencephalopathy syndrome (RPLS) occurs. Cabometyx is not recommended for use in patients with severe hepatic impairment (1).
The safety and efficacy of Cabometyx in pediatric patients have not been established (1).
Summary
Cabometyx is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma, Cabometyx FEP Clinical Rationale

CABOMETYX
(cabozantinib)
hepatocellular carcinoma, and has an off-label use for non-small cell lung cancer. Cabometyx should not be used in patients with reversible posterior leukoencephalopathy syndrome (RPLS). Cabometyx should be used with caution in patients at increased risk for thrombotic events, hemorrhagic events, gastrointestinal perforation and fistulas. Cabometyx should be stopped in patients with hypertensive crisis, diarrhea, or palmar-plantar erythrodysethesia syndrome (PPES). The safety and efficacy of Cabometyx in pediatric patients have not been established (1).
Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Cabometyx while maintaining optimal therapeutic outcomes.
References
1. Cabometyx [package insert]. Alameda, CA: Exelixis, Inc.; January 2019.
2. NCCN Drugs & Biologics Compendium® 2019. National Comprehensive Cancer Network, Inc.
January 2019.
3. NCCN Clinical Practice Guidelines in Oncology® Non-Small Cell Lung Cancer (Version 3. 2019).
National Comprehensive Cancer Network, Inc. January 2019.


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