FDA OKs Amgen Biosimilar to Treat Cancer

Sep 16, 2017

The U.S. FDA approved Amgen's Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of many types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

“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 Scott Gottlieb, M.D.

Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. For the specific, approved indications, click here.

Like Avastin, the labeling for Mvasi contains a Boxed Warning to alert health care professionals and patients about an increased risk of holes in the stomach and intestines (gastrointestinal perforations); surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding (hemorrhage).