Bevacizumab-awwb

(Mvasi®)

Mvasi®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous: 100 mg/4 mL [25 mg/mL] or 400 mg/16 mL [25 mg/mL] in a single-dose vial)
Drug ClassVascular endothelial growth factor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
  • Indicated for the treatment of metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  • Indicated for the treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
  • Indicated for the treatment of recurrent glioblastoma in adults.
  • Indicated for the treatment of metastatic renal cell carcinoma in combination with interferon-alfa.
  • Indicated for the treatment of persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
  • Indicated for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection; in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinumsensitive recurrent disease.

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Summary
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  • Mvasi (bevacizumab-awwb) is indicated for the treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment; the treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen; the treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel for first-line treatment; the treatment of recurrent glioblastoma in adults; the treatment of metastatic renal cell carcinoma in combination with interferon-alfa; the treatment of persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan; the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by Mvasi as a single agent, for stage III or IV disease following initial surgical resection; in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; and in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Mvasi as a single agent, for platinum-sensitive recurrent disease.
  • This summary is based on the review of 29 systematic review(s)/meta-analysis(es). [1-29]
  • Stronger anti-tumor activity and better disease control were noted compared to cetuximab, vandetanib, cediranib, and panitumumab (OR=1.30, 95% CI: 1.11-1.52; OR=1.36, 95% CI: 1.04-1.78; OR=1.94, 95% CI: 1.06-3.55). No significant improvement in overall survival (HR=0.98, 95% CI: 0.84-1.15) or progression-free survival (HR=1.05, 95% CI: 0.97-1.13) was observed.
  • Advanced Hepatocellular Carcinoma (HCC): Combination therapy with atezolizumab showed a pooled overall response of 26%, with a 2% complete response, 23% partial response, median overall survival of 14.7 months, and median progression-free survival of 6.66 months.
  • Low-Grade Serous Ovarian Cancer (LGSOC): Treatment demonstrated an improved overall response rate of 47.5%, indicating promising activity compared to conventional chemotherapy.
  • Metastatic Breast Cancer (MBC): Bevacizumab-containing regimens resulted in improved progression-free survival (HR=0.82, 95% CI 0.73-0.93) and objective response rate (RR=1.45, 95% CI 1.18-1.78), but did not significantly affect overall survival (HR=0.93, 95% CI 0.79-1.10).
  • General Adverse Events: High incidence of hypertension, proteinuria, and cardiovascular events; increased risk of gastrointestinal adverse reactions (OR=1.29, 95% CI: 1.07-1.55) and nonhematological toxicity.
  • Specific Adverse Events: Notable adverse events include a fourfold increase in severe hypertension and a twofold increase in arterial thromboembolism in metastatic colorectal cancer; 83% of patients with advanced hepatocellular carcinoma experienced adverse events, with 30% experiencing grade 3 and above. Increased incidence of anemia, thrombocytopenia, and other grade 3-4 events in non-small cell lung cancer.
  • Comparison with Other Drugs: Bevacizumab was associated with higher cardiovascular risks compared to cetuximab and panitumumab, which had more dermatological and renal adverse events; similar risks for serious adverse events when compared to PARPi, although PARPi had higher adverse risks compared to control groups.
  • Population analysis in studies of metastatic colorectal cancer (mCRC) included patients aged 55-75 years, with subgroup benefits observed in non-small cell lung cancer (NSCLC) patients aged <65 years; no gender-specific differences were noted, but increased cardiovascular risks were identified in patients with pre-existing vascular comorbidities when treated with bevacizumab. Additionally, patients with BRCA mutations showed better outcomes with PARPi over bevacizumab in ovarian cancer. Bevacizumab showed enhanced progression-free survival in HER2-negative metastatic breast cancer, and its induced hypertension may serve as a prognostic factor in recurrent glioblastoma.

Product Monograph / Prescribing Information

Document TitleYearSource
Mvasi (bevacizumab-awwb) Prescribing Information.2023Amgen, Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effectiveness of bevacizumab in the treatment of metastatic colorectal cancer: A systematic review and meta-analysis. 2024BMC Gastroenterology
Efficacy and safety of atezolizumab plus bevacizumab treatment for advanced hepatocellular carcinoma in the real world: A single-arm meta-analysis.2023BMC Cancer
Different doses of bevacizumab in combination with chemotherapy for advanced colorectal cancer: A meta-analysis and Bayesian analysis.2023International Journal of Colorectal Disease
Risks of hypertension and thromboembolism in patients receiving bevacizumab with chemotherapy for colorectal cancer: A systematic review and meta-analysis. 2023Cancer Medicine
Bevacizumab treatment for low-grade serous ovarian cancer: A systematic review.2023Current Oncology
Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.2023The Cochrane Database of Systematic Reviews
Efficacy and safety of bevacizumab in pretreated metastatic breast cancer : A systematic review and meta-analysis.2022Oncology Research and Treatment
Bevacizumab-induced hypertension as a potential physiological clinical biomarker for improved outcomes in patients with recurrent glioblastoma multiforme: A systematic review.2022Cureus
Tolerability on serious adverse events of first-line bevacizumab and cetuximab for RAS wild-type metastatic colorectal cancer: A systematic review and meta-analysis.2022Healthcare
Bevacizumab versus PARP-inhibitors in women with newly diagnosed ovarian cancer: A network meta-analysis.2022BioMed Central Cancer
The utilization of bevacizumab in patients with advanced ovarian cancer: A systematic review of the mechanisms and effects. 2022International Journal of Molecular Sciences
Efficacy and safety of metronomic chemotherapy in maintenance therapy for metastatic colorectal cancer: A systematic review of randomized controlled trials.2022Medicine
Safety assessment on serious adverse events of targeted therapeutic agents prescribed for RAS wild-type metastatic colorectal cancer: Systematic review and network meta-analysis.2022International Journal of Environmental Research and Public Health
The efficacy and safety of bevacizumab combined with FOLFOX regimen in the treatment of advanced colorectal cancer: A systematic review and meta-analysis.2021Medicine
The efficacy and toxicity of maintenance therapy with bevacizumab plus pemetrexed versus bevacizumab/pemetrexed alone for stage IIIB/IV nonsquamous non-small cell lung cancer: A meta-analysis of randomized controlled trials.2021Journal of Clinical Pharmacy and Therapeutics
The use of bevacizumab in the modern era of targeted therapy for ovarian cancer: A systematic review and meta-analysis.2021Gynecologic Oncology
Maintenance treatment of combination with bevacizumab vs single agent for advanced non-squamous non-small cell lung cancer: A systematic review and meta-analysis.2021Medicine
Reliability and toxicity of bevacizumab for neurofibromatosis type 2-related vestibular schwannomas: A systematic review and meta-analysis.2021American Journal of Otolaryngology
Vascular endothelial growth factor (VEGF) targeting therapy for persistent, recurrent, or metastatic cervical cancer. 2021The Cochrane Database of Systematic Reviews
Optimal therapies for recurrent glioblastoma: A Bayesian network meta-analysis. 2021Frontiers in Oncology
Treatment options for progression or recurrence of glioblastoma: A network meta-analysis. 2021The Cochrane Database of Systematic Reviews
Clinical option of pemetrexed-based versus paclitaxel-based first-line chemoterapeutic regimens in combination with bevacizumab for advanced non-squamous non-small-cell lung cancer and optimal maintenance therapy: Evidence from a meta-analysis of randomized control trials.2021BioMed Central Cancer
Radiotherapy versus combination radiotherapy-bevacizumab for the treatment of recurrent high-grade glioma: A systematic review. 2021Acta Neurochirurgica
A systematic review of glioblastoma-targeted therapies in phases II, III, IV clinical trials. 2021Cancers
Bevacizumab or PARP-inhibitors maintenance therapy for platinum-sensitive recurrent ovarian cancer: A network meta-analysis.2020International Journal of Molecular Medicine
Radiological recurrence patterns after bevacizumab treatment of recurrent high-grade glioma: A systematic review and meta-analysis. 2020Korean Journal of Radiology
Efficacy and safety of bevacizumab for vestibular schwannoma in neurofibromatosis type 2: A systematic review and meta-analysis of treatment outcomes.2019Journal of Neuro-Oncology
Comparative toxicities of neoadjuvant chemotherapy with or without bevacizumab in HER2-negative breast cancer patients: A meta-analysis.2019Annals of Pharmacotherapy
Bevacizumab improves survival in metastatic colorectal cancer patients with primary tumor resection: A meta-analysis.2019Scientific Reports

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