Difference between revisions of "Bevacizumab (Avastin)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2/26/2004: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125085ltr.pdf Initial FDA approval], "in combination with intravenous 5- | + | *2/26/2004: [http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125085ltr.pdf Initial FDA approval], "in combination with intravenous [[Fluorouracil (5-FU)|5-fluorouracil]]–based chemotherapy...for first- line treatment of patients with metastatic carcinoma of the [[Colon_cancer|colon]] or [[Rectal_cancer|rectum]]." |
*Subsequently FDA approved for: | *Subsequently FDA approved for: | ||
| − | **"Metastatic colorectal cancer, with intravenous 5- | + | **"Metastatic [[Colon_cancer|colorectal cancer]], with intravenous [[Fluorouracil (5-FU)|5-fluorouracil]]–based chemotherapy for first- or second-line treatment." |
| − | **"Metastatic colorectal cancer, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin containing regimen." | + | **"Metastatic [[Colon_cancer|colorectal cancer]], with [[Fluorouracil (5-FU)|fluoropyrimidine-]][[Irinotecan (Camptosar)|irinotecan-]] or [[Fluorouracil (5-FU)|fluoropyrimidine-]][[Oxaliplatin (Eloxatin)|oxaliplatin-]]based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin containing regimen." |
| − | **"Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease." | + | **"[[Non-small_cell_lung_cancer|'''Non-squamous''' non-small cell lung cancer]], with [[Carboplatin (Paraplatin)|carboplatin]] and [[Paclitaxel (Taxol)|paclitaxel]] for first line treatment of unresectable, locally advanced, recurrent or metastatic disease." |
| − | **"Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy." | + | **"[[Central_nervous_system_(CNS)_cancer|Glioblastoma]], as a single agent for adult patients with progressive disease following prior therapy." |
| − | **"Metastatic renal cell carcinoma with interferon alfa." | + | **"Metastatic [[Renal_cancer|renal cell carcinoma]] with [[Interferon alfa-2a (Roferon-A)|interferon alfa]]." |
| − | *8/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm410128.htm FDA approved] for treatment of "cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease." | + | *8/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm410128.htm FDA approved] for treatment of "[[Cervical_cancer|cervical cancer]], in combination with [[Paclitaxel (Taxol)|paclitaxel]] and [[Cisplatin (Platinol)|cisplatin]] or [[Paclitaxel (Taxol)|paclitaxel]] and [[Topotecan (Hycamtin)|topotecan]] in persistent, recurrent, or metastatic disease." |
| − | *11/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm423159.htm FDA approved] for treatment of "Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan." | + | *11/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm423159.htm FDA approved] for treatment of "Platinum-resistant recurrent [[Ovarian_cancer|epithelial ovarian, fallopian tube or primary peritoneal cancer]], in combination with [[Paclitaxel (Taxol)|paclitaxel]], [[Doxorubicin liposomal (Doxil)|pegylated liposomal doxorubicin]] or [[Topotecan (Hycamtin)|topotecan]]." |
==References== | ==References== | ||
Revision as of 15:34, 14 August 2015
General information
Class/mechanism: Monoclonal antibody that inhibits angiogenesis by binding VEGF and preventing the interaction of VEGF with its receptors (Flt-1 and KDR) on the surface of endothelial cells.[1][2][3]
Route: IV
Extravasation: no information
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, Medscape,UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- Breast cancer
- Central nervous system (CNS) cancer
- Cervical cancer
- Colon cancer
- Esophageal cancer
- Follicular lymphoma
- Hepatobiliary cancer
- Melanoma
- Neuroendocrine tumors
- Non-small cell lung cancer
- Ovarian cancer
- Renal cancer
- Sarcoma
- Unknown primary
- Uterine cancer
Information about counterfeit Bevacizumab (Avastin)
- FDA's 2/14/2012 statement about counterfeit Avastin in U.S.
- Genentech's 2/14/2012 statement on counterfeit drug labeled as Avastin (Bevacizumab) in the United States - contains pictures of authentic and counterfeit product
- Authorized specialty distributors, wholesalers and specialty pharmacies for Bevacizumab (Avastin)
Patient drug information
- Bevacizumab (Avastin) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found in the package insert[1]
- Bevacizumab (Avastin) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2/26/2004: Initial FDA approval, "in combination with intravenous 5-fluorouracil–based chemotherapy...for first- line treatment of patients with metastatic carcinoma of the colon or rectum."
- Subsequently FDA approved for:
- "Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment."
- "Metastatic colorectal cancer, with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin containing regimen."
- "Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease."
- "Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy."
- "Metastatic renal cell carcinoma with interferon alfa."
- 8/14/2014: FDA approved for treatment of "cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease."
- 11/14/2014: FDA approved for treatment of "Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan."
References
Categories:
- Drug index
- Chemotherapy
- Intravenous chemotherapy
- Antibody medications
- Anti-VEGF antibodies
- VEGF inhibitors
- Breast cancer medications
- Cancer of unknown primary medications
- Central nervous system (CNS) cancer medications
- Cervical cancer medications
- Colon cancer medications
- Esophageal cancer medications
- Follicular lymphoma medications
- Hepatobiliary cancer medications
- Melanoma medications
- Neuroendocrine tumor medications
- Non-small cell lung cancer medications
- Ovarian cancer medications
- Renal cancer medications
- Sarcoma medications
- Uterine cancer medications
- Drugs FDA approved in 2004