The U.S. Food and Drug Administration (FDA) has approved the first biosimilar for the treatment of cancer: Mvasi™ (bevacizumab-awwb). Mvasi is a biosimilar to Avastin® (bevacizumab) and like Avastin, it is approved to treat adults with certain types of brain, kidney, cervical, colorectal, and lung cancers. Specifically, in lung cancer, Mvasi is approved to treat non-squamous non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel for first line treatment of tumors that cannot be operated on (unresectable), are locally advanced, or recurrent or metastatic disease.1
What is a biosimilar?
Biosimilars are highly similar to an already approved biological product. Biological products (and biosimilars) are made from living organisms. The sources used to create biological products may be human, animal, bacteria, or yeast.2,3
Unlike generics, which have the same chemical structure and are exact copies of a reference medicine, biosimilars aren’t exactly like their reference biologics. Biosimilars are generally cheaper than their reference medicine, and they provide another treatment option for patients. Biosimilars must undergo rigorous testing in large clinical trials before they receive approval, and the FDA only approves biosimilars that have the same mechanism of action, route of administration, dosage form, and strength as the reference product.2,3
How does Mvasi work?
Like Avastin, Mvasi is a recombinant immunoglobulin G1 (IgG1) monoclonal antibody that binds to and inhibits vascular endothelial growth factor (VEGF). By blocking VEGF, Mvasi inhibits the growth of new blood vessels, which are necessary for the growth of solid tumors.4
What are the possible side effects of Mvasi?
In clinical trials, the most common side effects experienced by people taking Mvasi were nose bleeds (epistaxis), headache, high blood pressure (hypertension), inflammation of the nasal cavity (rhinitis), high levels of protein in the urine (proteinuria), taste alteration, dry skin, rectal bleeding (hemorrhage), excessive tear production (lacrimation disorder), back pain and skin irritation (exfoliative dermatitis).1,5
Mvasi has a black box warning – the strictest warning from the FDA, which alerts doctors and patients that the product has the potential to cause serious side effects. Some people taking Mvasi have experienced serious side effects such as:
Perforation (holes) in the gastrointestinal tract (occurs in an estimated 3.2% of people taking Mvasi)
Surgery and wound healing complications
Hemorrhage (severe bleeding), which may occur as pulmonary (lungs), gastrointestinal, central nervous system, or vaginal bleeding and may be fatal1,5
Other serious side effects that may occur with Mvasi include holes in or abnormal connection between two organs (perforation or fistula), blood clot formation (arterial and venous thromboembolic events), hypertension, problems in brain function or structure (posterior reversible encephalopathy syndrome), high levels of protein in the urine (proteinuria), infusion-related reactions and loss of function of the ovaries (ovarian failure). Mvasi should be discontinued if any of these occur or if these side effects become life-threatening.1,5
Things to know about Mvasi
Mvasi should not be used by pregnant women as Mvasi may cause harm to a developing fetus. Women of reproductive age should use contraception while taking Mvasi and for six months after their last dose of Mvasi. Mvasi may impair fertility.2,5
Breastfeeding is not recommended during treatment with Mvasi.2,5
Mvasi should not be used for at least 28 days prior to major surgery and for at least 28 days following major surgery, as it can delay the healing of surgical wounds.2,5
Mvasi is given as an intravenous (IV) infusion. For NSCLC, the recommended dose of Mvasi is 15 mg/kg every three weeks with carboplatin and paclitaxel.5
U.S. Food and Drug Administration press release. Accessed online on 9/14/17 at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm.
Amgen Biosimilars. Accessed online on 9/14/17 at http://www.amgenbiosimilars.com/the-basics/biosimilars-versus-generics/
Biosimilars, U.S. Food and Drug Administration. Accessed online on 9/14/17 at https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241718.htm.
Amgen press release. Accessed online on 9/14/17 at http://www.amgen.com/media/news-releases/2017/09/fda-approves-amgen-and-allergans-mvasi-bevacizumabawwb-for-the-treatment-of-five-types-of-cancer/.
Mvasi prescribing information. Accessed online on 9/15/17 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf.