FDA OKs Biosimilar Treatment for Certain Breast and Stomach Cancers

DECEMBER 01, 2017
The FDA has approved trastuzumab-dkst (Ogivri, Mylan GmbH) as a biosimilar to trastuzumab (Herceptin, Genentech), the first biosimilar for the treatment of certain breast and stomach cancers.

The treatment is indicated for patients with HER2+ breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Ogivri is not approved as an interchangeable product.

The approval is based on review of evidence that included extensive structural and functional characterizations, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.

A boxed warning is included in the labeling to alert health care providers and patients about increased risks of heart disease, infusions reactions, lung damage, and harm to a developing fetus.

The treatment should be stopped in the event of cardiomyopathy, life-threatening allergic reactions, swelling below the skin, inflammation of the lungs, or fluid in the lungs, according to an FDA statement. Health care providers should also advise patients of the potential risk to a developing fetus and to use effective contraception.

Common adverse effects associated with the use of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, difficulty sleeping, cough, and rash. For the treatment of HER2+ metastatic stomach cancer, common expected adverse effects 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 mucous membranes, common cold, and unusual taste sensation.

In the clip below, Marcus H. Snow, MD, from the University of Nebraska Medical Center, provides advice on how pharmacists can counsel patients on biologic treatments.


FDA approves first biosimilar for the treatment of certain breast and stomach cancers [news release]; December 1, 2017. . Accessed December 1, 2017.