Note: this article provided by ONU Healthwise Pharmacy.
The US Food and Drug Administration (FDA) has approved another biosimilar to a drug that treats breast, stomach and esophageal cancer.
This biosimilar is called Kanjinti (trastuzumab-anns). The FDA approved it because it appeared to have no meaningful differences from Herceptin (trastuzumab), which has already been approved.
If a drug is a biosimilar to another drug, that means it is nearly identical to the other drug (called the reference product). According to the FDA's recent approval, Kanjinti is a biosimilar to Herceptin.
Similarly to Herceptin, the FDA approved Kanjinti to treat certain advanced cancers of the breast, stomach and esophagus. Kanjinti comes in the same dosage and strength as Herceptin.
When used to treat breast cancer, Kanjinti's potential side effects may include nausea, vomiting, fever, infusion reactions, infections, diarrhea, cough, headache, rash and fatigue, among others. When used to treat gastric cancer, Kanjinti's potential side effects may include anemia, fatigue, diarrhea, weight loss, fever and upper respiratory tract infections, among other side effects.
Kanjinti also comes with the same boxed warnings as Herceptin. These warnings point to potentially serious adverse effects tied to the use of this drug. These potential effects include a risk of serious cardiovascular problems, severe infusion reactions like anaphylaxis and acute respiratory distress and harm to an unborn baby.
The FDA granted approval of Kanjinti to Amgen and Allergan.
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