MVASI™ is highly similar to Avastin® based on a totality of evidence, with no clinically meaningful differences in safety of efficacy.1,3
The MAPLE comparative clinical trial was conducted in the non-squamous non-small cell lung cancer (NSCLC) setting.1
*Conducting biosimilar studies in this sensitive population provides scientific evidence supporting extrapolation to less sensitive populations.1
Extrapolation is the approval of a biosimilar drug for an indication held by the reference drug without direct studies of the biosimilar for that indication.9
Comparative clinical study (MAPLE)
Non-squamous non-small cell lung cancer (N = 642)
Clinical pharmacology data
Analytical and nonclinical studies
Multiple in vitro analytical studies and in vivo analytical studies, including toxicology
Scientific justification for similarity
The FDA extrapolates these data to consider approval of the biosimilar for all reference drug indications.
APPROVED INDICATIONS FOR MVASI™2
The MVASI™ biosimilarity program, including choice of NSCLC population, was designed based on FDA guidance.4
*MVASI™ is not currently indicated for ovarian cancer, for which Avastin® has orphan status.10
‡Totality of evidence establishes structural and functional equivalence, and includes nonclinical evaluation, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and comparative clinical study data.3
PD = pharmacodynamic; PK = pharmacokinetic.
MVASI™ IS THE FIRST FDA-APPROVED ONCOLOGY THERAPEUTIC BIOSIMILAR11
MVASI™ Important Safety Information
Most common adverse events
Indication-specific adverse events
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Amgen at 1-800-772-6436.
Please see full Prescribing Information for additional Important Safety Information.
MVASI™ is a vascular endothelial growth factor inhibitor indicated for the treatment of:
MVASI™, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer.
MVASI™, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: MVASI™ is not indicated for adjuvant treatment of colon cancer.
MVASI™, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.
MVASI™ is indicated for the treatment of recurrent glioblastoma in adults.
MVASI™, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma.
MVASI™, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
References: 1. Thatcher N, Goldschmidt JH, Thomas M, et al. Efficacy and safety of the biosimilar ABP 215 compared with bevacizumab in patients with advanced nonsquamous non-small cell lung cancer (MAPLE): a randomized, double-blind, phase III study. Clin Cancer Res. 2019;25:2088-2095. 2. MVASI™ (bevacizumab-awwb) Prescribing Information, Amgen. 3. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Accessed June 8, 2019. 4. US Food and Drug Administration. FDA webinar - overview of the regulatory framework and FDA's guidance for the development and approval of biosimilar and interchangeable products in the US. Accessed June 8, 2019. 5. Markus R, Chow V, Pan Z, et al. A phase I, randomized, single-dose study evaluating the pharmacokinetic equivalence of biosimilar ABP 215 and bevacizumab in healthy adult men. Cancer Chemother Pharmacol. 2017;80:755-763. 6. Data on file, Amgen [3.2.R Analytical Similarity Assessment - Biological Activity]. 7. Data on file, Amgen [2.6.6 Toxicology Written Summary]. 8. Data on file, Amgen [2.6.2 Pharmacology Written Summary]. 9. US Food and Drug Administration. Biosimilar development, review, and approval. Accessed June 8, 2019. 10. US Food and Drug Administration. Search: orphan drug designations and approvals. Accessed June 8, 2019. 11. US Food and Drug Administration. FDA approves first biosimilar for cancer treatment. Accessed June 8, 2019.