Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Avastin is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. FDA label
Also known as Avastin, Bevacizumab (avastin)
Bevacizumab · 5 trials · 5 indications
PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
pharmacokinetic study
Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").
Percentage of participants with objective response (OR) based assessment of confirmed complete response(CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all lesions and no appearance of new lesions. Confirmed PR defined as \>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as reference the baseline sum LD , without progression of nontarget lesions and no appearance of new lesions. Confirmed responses are those that persist on repeat imaging study \>=4 weeks after initial documentation of response.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Bevacizumab 10 mg/kg intravenous (IV) q8wks + Temsirolimus 25 mg IV weekly |
| 2 | ACTIVE_COMPARATOR | Bevacizumab 10 mg/kg intravenous (IV) q8wks + Interferon-Alfa 9MU SC TIW |
| triweekly then biweekly | EXPERIMENTAL | The arm A consisted of 2 cycles of triweekly TOMOX (standard dose 3mg/m2 of Raltitrexed in 15-minutes infusion, and 130mg/m2 of oxaliplatin in 2h infusion, every 3 weeks), followed by 2 cycles of biweekly TOMOX (2mg/m2 of Raltitrexed in 15-minutes infusion, and 85mg/m2 of oxaliplatin in 2h infusion, every 2 weeks). |
| biweekly then triweekly | EXPERIMENTAL | The arm B consisted of the reserve sequence starting with 2 cycles of biweekly TOMOX followed by 2 cycles of triweekly TOMOX regimen. |
| B | ACTIVE_COMPARATOR | Bevacizumab will be administered in combination with carboplatin and paclitaxel. |
| A | EXPERIMENTAL | AG-013736 will be administered in combination with carboplatin and paclitaxel. |
| C | EXPERIMENTAL | AG-013736 (axitinib) |
| D | ACTIVE_COMPARATOR | bevacizumab (avastin) |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab 10 mg/kg intravenous (IV) q8wks |
| Temsirolimus | DRUG | Temsirolimus 25 mg IV weekly |
| Interferon-Alfa 9MU | DRUG | Interferon-Alfa 9MU SC TIW |
| TOMOX | DRUG | - |
| Carboplatin | DRUG | Carboplatin is available as pre-mixed 10mg /ml aqueous solution- The starting dose is AUC 6 mg\*min/ml, iv infusion, every 3 weeks. |
| Paclitaxel | DRUG | Paclitaxel is available in multidose vials (30 mg/5ml;100mg/16.7 ml;300 mg/50ml)- The starting dose is 200 mg/m2, every 3 weeks |
| AG-013736 (axitinib) | DRUG | AG-013736 (axitinib) is available as 1mg, and 5 mg film-coated tablets for oral administration- The starting dose is 5 mg BID- |
| Bevacizumab (avastin) | DRUG | Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent. |
| FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) | DRUG | Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. |
| FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) | DRUG | Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent. |
| AG-013726 | DRUG | AG-013726 5 mg bid every 2 weeks |
Inclusion Criteria: * Histologically and/or cytologically confirmed to have advanced renal cell carcinoma (RCC) * Majority component of conventional clear-cell type is mandatory * At least 1 measurable lesion (per RECIST) Exclusion Criteria: * Prior systemic treatment for RCC * Evidence of curren...
Bevacizumab is a monoclonal antibody studied in oncology for several solid tumor types, including metastatic colorectal cancer, non-small-cell lung carcinoma, and renal cell carcinoma. It is also known as Avastin. It is an investigational agent in the clinical development programs described here and has been evaluated in randomized, active-controlled trials.
Bevacizumab targets VEGFA, a vascular endothelial growth factor. It is classified as an inhibitor of this target. By binding VEGFA, the antibody is designed to interfere with vascular endothelial growth factor signaling, a pathway involved in tumor blood vessel formation and growth.
Bevacizumab is developed by Pfizer, Inc., which trades under the ticker PFE. The company is listed as the developer of the clinical programs evaluating the drug across colorectal, lung, and renal cancer indications.
Bevacizumab is in clinical development, with Phase 2 and Phase 3 studies reported. The trials listed are completed, and no active trials are currently recorded. It is investigational and is not described as approved in this program data.
Completed studies include NCT02821559, a Phase 2 trial of biweekly versus triweekly raltitrexed with oxaliplatin with or without bevacizumab in first-line metastatic colorectal cancer, and NCT00631371, a Phase 3 study comparing bevacizumab plus temsirolimus versus bevacizumab plus interferon-alfa in advanced renal cell carcinoma.
Yes, Bevacizumab is also known as Avastin. The names refer to the same monoclonal antibody, and trial titles in this program use both forms, including references to bevacizumab (Avastin). Searches for either name point to the same agent.