User talk:Javaweb/Avastin
Indications
[edit]For cancers such as breast cancer, lung cancer, and certain renal (kidney) cancers, bevacizumab has been shown to improve the progression free survival, not overall survival. It has not been shown to affect survival time.
Colorectal cancer
[edit]Bevacizumab was approved by the FDA in February 2004 for use in metastatic colorectal cancer when used with standard chemotherapy treatment (as first-line treatment) and with 5-fluorouracil-based therapy for second-line metastatic colorectal cancer. This recommendation was based on E3200 trial - addition of bevacizumab to oxaliplatin/5-FU/leucovorin (FOLFOX4) therapy. It was approved by the EMEA in January 2005 for use in colorectal cancer.[citation needed]
Lung cancer
[edit]In 2006, the FDA approved bevacizumab for use in lung cancer in combination with standard first-line chemotherapy. A study conducted by the Eastern Cooperative Oncology Group (ECOG) demonstrated a 2-month improvement in overall survival in patients with Stage IIIb/IV non-small cell lung cancer (NSCLC). However, other studies have unfortunately not mirrored this finding, and overall data shows that bevacizumab has no effect on survival in lung cancer. Due to the observance of severe pulmonary hemorrhage in patients with NSCLC with squamous histology in an earlier study, patients with such histology were excluded from the pivotal ECOG trial.
Breast cancer
[edit]On December 16, 2010, the FDA initiated the process to remove the breast cancer indication from Avastin. saying the, "Drug [has] not [been] shown to be safe and effective in breast cancer patients." In any case, the drug will still be available for the next few months while Genentech appeals the decision. This has no affect on its use in non-breast cancer treatment.[1],[2] In 2008, the FDA approved Bevacizumab for use in breast cancer. A panel of outside advisers voted 5 to 4 against approval, but their recommendations were overruled. The panel expressed concern that data from the clinical trial did not show any increase in quality of life or prolonging of life for patients - two important benchmarks for late-stage cancer treatments. The clinical trial did show that bevacizumab reduced tumor volumes and showed an increase in progression free survival time. It was based on this data that the FDA chose to overrule the recommendation of the panel of advisers. This decision was lauded by patient advocacy groups and some oncologists. Other oncologists felt that granting approval for late-stage cancer therapies that did not prolong or increase the quality of life for patients would give license to pharmaceutical companies to ignore these important benchmarks when developing new late-stage cancer therapies.[3] On March 28, 2007, the European Commission approved bevacizumab in combination with paclitaxel for the first-line treatment of metastatic breast cancer.[4]
In 2010, before the FDA announcement, The National Comprehensive Cancer Network® (NCCN®) updated the NCCN Clinical Practice Guidelines for Oncology (NCCN Guidelines™) for Breast Cancer to affirm the recommendation regarding the use of bevacizumab (Avastin®, Genentech/Roche) in the treatment of metastatic breast cancer.
Other cancers
[edit]In 2009, the FDA approved Bevacizumab for use in metastatic renal cell cancer (a form of kidney cancer) which is the drug's sixth indication[5] ,[6] following earlier reports of activity[7] and EU approval in 2007. Also in 2009, an FDA advisory committee unanimously recommended Bevacizumab for treatment of glioblastoma multiforme, a type of brain cancer.[8]
In the September 2009 issue of the Journal of Clinical Oncology, UCLA researchers reported that Avastin improves response and survival in patients with recurrent glioblastoma in comparison to historical controls.[9] Avastin may also be useful in the treatment of radiation necrosis, since it reduces edema and mass effect and diminishes blood-brain-barrier leakage.
Bevacizumab did not meet its primary endpoint of extending overall survival (OS) in a recent phase III trial in unresectable gastric cancer (in combination with paclitaxel / Taxol), but it did demonstrate a positive result in treatment of ovarian cancer.
Drug administration
[edit]Bevacizumab is usually given intravenously through the arm every 14 days. In colon cancer, it is given in combination with the chemotherapy drug 5-FU (5-fluorouracil), leucovorin, and oxaliplatin or irinotecan.
References
[edit]- ^ "FDA begins process to remove breast cancer indication from Avastin label" (Press release). FDA. 2010-12-16. Retrieved 2010-12-17.
- ^ Andrew Pollack (December 16, 2010). "F.D.A. Rejects Use of Drug in Cases of Breast Cancer". NY Times. Retrieved 2010-12-16.
- ^ Cite error: The named reference
nytimesrefwas invoked but never defined (see the help page). - ^ Jasek, W, ed. (2007). Austria-Codex (in German) (2007/2008 ed.). Vienna: Österreichischer Apothekerverlag. ISBN 3-85200-181-4.
{{cite book}}: Check|isbn=value: checksum (help) - ^ FDA clears Genentech drug for kidney cancer San Francisco Chronicle, August 2, 2009
- ^ http://www.genengnews.com/news/bnitem.aspx?name=59562374 "FDA Gives Roche's Avastin the Go-Ahead for Metastatic Renal Carcinoma "
- ^ Rini BI (2007). "Vascular endothelial growth factor-targeted therapy in renal cell carcinoma: current status and future directions". Clin Cancer Res. 13 (4): 1098–106. doi:10.1158/1078-0432.CCR-06-1989. PMID 17317817.
{{cite journal}}: Unknown parameter|month=ignored (help) - ^ Pollack, Andrew (2009-03-31). "F.D.A. Panel Supports Avastin to Treat Brain Tumor". New York Times. Retrieved 2009-08-13.
- ^ OncoGenetics.Org (2009). "Avastin dramatically improves response, survival in deadly recurrrent glioblastomas". OncoGenetics.Org. Retrieved 2009-09-02.
{{cite web}}: Unknown parameter|month=ignored (help) [dead link]