Difference between revisions of "Bevacizumab (Avastin)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| + | ===[[Breast cancer]]=== | ||
| + | *2/22/2008: Granted accelerated approval for use in combination with [[Paclitaxel (Taxol)|paclitaxel]] for the treatment of patients who have not received chemotherapy for metastatic [[Breast_cancer|HER2 negative breast cancer]]. ''(New disease entity)'' | ||
| + | |||
===[[Cervical cancer]]=== | ===[[Cervical cancer]]=== | ||
| − | *8/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm410128.htm | + | *8/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm410128.htm 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. ''(New disease entity)'' |
===Colorectal cancer=== | ===Colorectal cancer=== | ||
*'''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]]. | *'''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]]. | ||
| − | *6/20/2006: | + | *6/20/2006: Approved for second-line treatment of metastatic carcinoma of the [[Colon_cancer|colon]] or [[Rectal_cancer|rectum]]. ''(New treatment setting without requirement for combination therapy)'' |
===[[Non-small cell lung cancer]]=== | ===[[Non-small cell lung cancer]]=== | ||
| − | *10/11/2006: | + | *10/11/2006: Approved as a first-line treatment of patients with locally advanced, metastatic or recurrent [[non-small cell lung cancer]] in combination with platinum-based chemotherapy. ''(New disease entity)'' |
| − | ** | + | **[[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. ''(Label restricted to non-squamous histology only)'' |
===[[Ovarian cancer]]=== | ===[[Ovarian cancer]]=== | ||
| − | *11/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm423159.htm | + | *11/14/2014: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm423159.htm Approved] for treatment of platinum-resistant recurrent [[Ovarian_cancer|epithelial ovarian, fallopian tube or primary peritoneal cancer]], in combination with [[Paclitaxel (Taxol)|paclitaxel]], [[Pegylated liposomal doxorubicin (Doxil)|pegylated liposomal doxorubicin]] or [[Topotecan (Hycamtin)|topotecan]]. ''(New disease entity)'' |
| − | *6/13/2018: | + | *6/13/2018: Approved for patients with [[Ovarian_cancer|epithelial ovarian, fallopian tube, or primary peritoneal cancer]] in combination with [[Carboplatin (Paraplatin)|carboplatin]] and [[Paclitaxel (Taxol)|paclitaxel]], followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. ''(Indication expanded to first-line setting)'' |
===Other (unsorted)=== | ===Other (unsorted)=== | ||
| − | ** | + | **Metastatic [[Colon_cancer|colorectal cancer]], with intravenous [[Fluorouracil (5-FU)|5-fluorouracil]]–based chemotherapy for first- or second-line treatment. |
| − | ** | + | **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. |
| − | ** | + | **[[Central_nervous_system_(CNS)_cancer|Glioblastoma]], as a single agent for adult patients with progressive disease following prior therapy. |
| − | ** | + | **Metastatic [[Renal_cell_carcinoma|renal cell carcinoma]] with [[Interferon alfa-2a (Roferon-A)|interferon alfa]]. |
==Also known as== | ==Also known as== | ||
Revision as of 03:34, 27 November 2018
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: neutral
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
- Adenocarcinoma of unknown primary
- Anaplastic glioma
- Breast cancer
- Cervical cancer
- Cholangiocarcinoma
- Colon cancer
- Esophageal cancer
- Follicular lymphoma
- Glioblastoma
- Hepatocellular carcinoma
- Melanoma
- Mesothelioma
- Neuroendocrine tumors
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic NET
- Renal cell carcinoma
- Small cell lung cancer
- Testicular cancer
- Endometrial cancer
- Vascular sarcoma
Information about counterfeit bevacizumab
- 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
Breast cancer
- 2/22/2008: Granted accelerated approval for use in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2 negative breast cancer. (New disease entity)
Cervical cancer
- 8/14/2014: Approved for treatment of cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease. (New disease entity)
Colorectal cancer
- 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.
- 6/20/2006: Approved for second-line treatment of metastatic carcinoma of the colon or rectum. (New treatment setting without requirement for combination therapy)
Non-small cell lung cancer
- 10/11/2006: Approved as a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy. (New disease entity)
- Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease. (Label restricted to non-squamous histology only)
Ovarian cancer
- 11/14/2014: Approved for treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan. (New disease entity)
- 6/13/2018: Approved for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. (Indication expanded to first-line setting)
Other (unsorted)
- 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.
- Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy.
- Metastatic renal cell carcinoma with interferon alfa.
Also known as
- Generic name: rhuMab-VEGF
- Brand names: Altuzan, Avastin, BevaciRel, Bevarest
References
Categories:
- Drugs
- Intravenous medications
- Neutral chemotherapy
- Antibody medications
- Anti-VEGFR antibodies
- VEGFR inhibitors
- Adenocarcinoma of unknown primary medications
- Anaplastic glioma medications
- Breast cancer medications
- Cervical cancer medications
- Cholangiocarcinoma medications
- Colon cancer medications
- Esophageal cancer medications
- Follicular lymphoma medications
- Glioblastoma medications
- Hepatocellular carcinoma medications
- Melanoma medications
- Mesothelioma medications
- Neuroendocrine tumor medications
- Non-small cell lung cancer medications
- Ovarian cancer medications
- Pancreatic NET medications
- Renal cell carcinoma medications
- Small cell lung cancer medications
- Testicular cancer medications
- Endometrial cancer medications
- Vascular sarcoma medications
- FDA approved in 2004
- PMDA approved drugs