The FDA has approved Mvasi (bevacizumab-awwb, Amgen/Allergan) as a biosimilar to Avastin (bevacizumab, Genentech) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney, and cervical cancers. Specifically, the approved indications include:
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.
Biological products are generally derived from a living organism and can come from many sources, such as humans, animals, microorganisms, or yeast. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity, and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.
The FDA’s approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product.
Like Avastin, the labeling for Mvasi contains a boxed warning to alert health care professionals and patients about an increased risk of gastrointestinal perforations; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding (hemorrhage).
Common expected side effects of Mvasi include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal bleeding (hemorrhage), lacrimation disorder, back pain, and exfoliative dermatitis. Serious expected side effects of Mvasi include holes in or abnormal connection between two organs (perforation or fistula), arterial and venous thromboembolic events, hypertension, problems in brain function or structure (posterior reversible encephalopathy syndrome), proteinuria, infusion-related reactions, and ovarian failure. Patients should stop using Mvasi if these side effects become severe or life-threatening. Women who are pregnant should not take Mvasi because it may cause harm to a developing fetus.
Source: FDA; September 14, 2017.