Mvasi Is First Biosimilar Drug Approved for Cancer
THURSDAY, Sept. 14, 2017 -- The first biosimilar drug to treat cancer has been approved by the U.S. Food and Drug Administration.
Biosimilar drugs are typically derived from living organisms and are approved after manufacturers demonstrate that the medications are "highly similar" to already approved drugs, the agency said.
Mvasi is approved to treat certain cancers of the colon, lung, brain, kidney and cervix, the FDA said.
"Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies," said FDA Commissioner Dr. Scott Gottlieb. He pledged new biosimilar drugs would be brought to market quickly, although subject to FDA's "rigorous gold standard for safety and effectiveness."
The most common side effects of Mvasi include nose bleed, headache, high blood pressure, nasal inflammation, abnormally high urinary protein, changes in taste and dry skin. More serious adverse reactions could include abnormal connections between internal organs, blood clots, high blood pressure and problems with brain function.
Like Avastin, labeling for Mvasi will warn of increased risk of gastrointestinal holes, complications after surgery and severe bleeding of the lungs, stomach, intestines, central nervous system and female genitalia.
Mvasi's approval was given to Amgen, based in Thousand Oaks, Calif. Avastin is produced by Genentech Inc.
The FDA has more about this approval.
Posted: September 2017