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Title | Avastin (bevacizumab) FDA Drug Label |
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125085 |
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Bevacizumab | Bevacizumab | 7 | 120 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Bevacizumab | Avastin | VEGF Antibody 11 VEGFR Inhibitor (Pan) 32 | Avastin (bevacizumab) is a monoclonal antibody that binds VEGF and inhibits binding to VEGFR, potentially resulting in decreased tumor growth (PMID: 15136787). Avastin (bevacizumab) is FDA approved for use in colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical carcinoma, and ovarian cancer, and in combination with carboplatin and paclitaxel in epithelial ovarian, fallopian tube, or primary peritoneal cancer (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Unknown unknown | ovary epithelial cancer | not applicable | Bevacizumab + Carboplatin + Paclitaxel | FDA approved | Actionable | In a Phase III trial (GOG-0218) that supported FDA approval, addition of Avastin (bevacizumab) during and after Paraplatin (carboplatin) plus Taxol (paclitaxel) treatment prolonged progression-free survival (14.1 vs 10.3 months) compared to placebo in patients with previously untreated, stage III/IV epithelial ovarian, primary peritoneal, or fallopian tube cancer (PMID: 22204724; NCT00262847). | detail... 22204724 |
Unknown unknown | colorectal cancer | not applicable | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin | FDA approved | Actionable | In a Phase III clinical trial that supported FDA approval, the combination of Avastin (bevacizumab) and FOLFIRI chemotherapy demonstrated increased duration of overall survival and improved progression-free survival compared to FOLFIRI alone in patients with metastatic colorectal cancer (PMID: 22477726, PMID: 15175435). | 15175435 22477726 detail... |
Unknown unknown | cervix carcinoma | not applicable | Bevacizumab + Paclitaxel + Topotecan | FDA approved | Actionable | In a Phase III trial that supported FDA approval, the addition of Avastin (bevacizumab) to Hycamtin (topotecan) and Taxol (paclitaxel) chemotherapy resulted in improved overall survival and progression-free survival compared to chemotherapy alone in patients with cervical cancer (PMID: 25281440, PMID: 24552320). | 25281440 24552320 detail... |
Unknown unknown | peritoneum cancer | not applicable | Bevacizumab + Carboplatin + Paclitaxel | FDA approved | Actionable | In a Phase III trial (GOG-0218) that supported FDA approval, addition of Avastin (bevacizumab) during and after Paraplatin (carboplatin) plus Taxol (paclitaxel) treatment prolonged progression-free survival (14.1 vs 10.3 months) compared to placebo in patients with previously untreated, stage III/IV epithelial ovarian, primary peritoneal, or fallopian-tube cancer (PMID: 22204724; NCT00262847). | detail... 22204724 |
Unknown unknown | colon cancer | not applicable | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin | FDA approved | Actionable | In a Phase III clinical trial that supported FDA approval, the combination of Avastin (bevacizumab) and FOLFIRI chemotherapy demonstrated increased duration of overall survival and improved progression-free survival compared to FOLFIRI alone in patients with metastatic colorectal cancer (PMID: 22477726, PMID: 15175435). | 15175435 22477726 detail... |
Unknown unknown | lung non-small cell carcinoma | not applicable | Bevacizumab + Carboplatin + Paclitaxel | FDA approved | Actionable | In an open-label trial that supported FDA approval, treatment with the combination of Avastin (bevacizumab) with Paraplatin (carboplatin) and Taxol (paclitaxel) resulted in improved overall survival compared to Paraplatin (carboplatin) and Taxol (paclitaxel) alone in patients with advanced non-small cell lung cancer (PMID: 17602060). | 17602060 detail... |
Unknown unknown | renal cell carcinoma | not applicable | Alpha 2 Interferon + Bevacizumab | FDA approved | Actionable | In a Phase III clinical trial that supported FDA approval, treatment with the combination of Avastin (bevacizumab) and Roferon (interferon alpha 2a) resulted in improved progression-free survival in patients with metastatic renal cell carcinoma compared to Roferon (interferon alpha 2a) with placebo (PMID: 20061402). | 20061402 detail... |
Unknown unknown | ovarian cancer | not applicable | Bevacizumab | FDA approved | Actionable | In a Phase III trial that supported FDA approval, ovarian cancer patients treated with Avastin (bevacizumab) combined with chemotherapy versus chemotherapy alone resulted in a greater PFS (6.7 mo vs 3.4 mo), overall response rate (27.3% vs 11.8%), and OS (16.6 mo vs 13.3 mo) (PMID: 24637997). | detail... 24637997 |
Unknown unknown | cervix carcinoma | not applicable | Bevacizumab + Cisplatin + Paclitaxel | FDA approved | Actionable | In a Phase III trial that supported FDA approval, the addition of Avastin (bevacizumab) to Platinol (cisplatin) and Taxol (paclitaxel) chemotherapy resulted in improved overall survival and progression-free survival compared to chemotherapy alone in patients with cervical cancer (PMID: 25281440, PMID: 24552320). | detail... 25281440 24552320 |
Unknown unknown | glioblastoma | not applicable | Bevacizumab | FDA approved | Actionable | In a Phase II trial that supported FDA approval, treatment with Avastin (bevacizumab) resulted in an objective response rate of 25.9% (22/85) with a mean duration of response of 4.2 months in patients with glioblastoma (PMID: 19897538). | detail... 19897538 |
Unknown unknown | fallopian tube cancer | not applicable | Bevacizumab + Carboplatin + Paclitaxel | FDA approved | Actionable | In a Phase III trial (GOG-0218) that supported FDA approval, addition of Avastin (bevacizumab) during and after Paraplatin (carboplatin) plus Taxol (paclitaxel) treatment prolonged progression-free survival (14.1 vs 10.3 months) compared to placebo in patients with previously untreated, stage III/IV epithelial ovarian, primary peritoneal, or fallopian tube cancer (PMID: 22204724; NCT00262847). | detail... 22204724 |