Drug updated on 9/4/2024
Dosage Form | Injection (intravenous: 100 mg/4 mL [25 mg/mL] or 400 mg/16 mL [25 mg/mL] in a single-dose vial) |
Drug Class | Vascular 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
- 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 Title | Year | Source |
---|---|---|
Mvasi (bevacizumab-awwb) Prescribing Information. | 2023 | Amgen, Inc., Thousand Oaks, CA |