publication date: Dec. 1, 2017

Drugs and Targets FDA approves Ogivri, first biosimilar for treating breast and stomach cancers

FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene.

Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. Ogivri is sponsored by Mylan GmbH.

FDA’s approval of Ogivri is based on review of extensive data that demonstrates Ogivri is biosimilar to Herceptin. Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Ogivri for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, difficulty sleeping, cough and rash.

Common expected side effects of Ogivri for the treatment of HER2+ metastatic stomach cancer include low levels of certain white blood cells, diarrhea, fatigue, low levels of red blood cells, inflammation of the mouth, weight loss, upper respiratory tract infections, fever, low levels of blood platelets, swelling of the mucous membranes, common cold and unusual taste sensation. Serious expected side effects of Ogivri include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labeling for … Continue reading FDA approves Ogivri, first biosimilar for treating breast and stomach cancers

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Copyright (c) 2017 The Cancer Letter Inc.