The FDA approved Ogivri (trastuzumab-dkst), a biosimilar drug to Herceptin (trastuzumab), to treat patients with breast or metastatic stomach cancer. Ogivri is the first biosimilar approved in the U.S. for the treatment of breast or stomach cancer.
Common side effects associated with Ogivri for the treatment of breast cancer include headache, nausea, chills, fever, infection, congestive heart failure, insomnia, cough and rash. A few side effects associated with the drug’s treatment of stomach cancer include low levels of certain white blood cells, diarrhea, fatigue and low levels of red blood cells. On the more alarming side, Ogivri may disrupt a patient’s cancer treatment and increase the risk of infection.
“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, MD.
Like Herceptin, Ogivri’s labeling contains a Black Box warning alerting doctors and patients about increased risks of heart disease, infusions reactions, lung damage, and harm to an unborn baby.