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FDA approves Trazimera, Herceptin biosimilar, for certain breast, gastric cancers
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The FDA approved trastuzumab-qyyp for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.
Trastuzumab-qyyp (Trazimera, Pfizer) is a monoclonal antibody biosimilar to trastuzumab (Herceptin, Genentech), which targets HER2.
“Approximately 15% to 30% of breast cancers and 10% to 30% of gastric cancers are HER2 positive, which is associated with aggressive disease and poor prognoses for patients,” Mark Pegram, MD, associate director for clinical research at Stanford Comprehensive Cancer Institute and director of the breast oncology program at Stanford Women’s Cancer Center, said in a manufacturer-issued press release. “With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need.”
The FDA approval was based on review of a comprehensive data package that demonstrated a high degree of similarity between trastuzumab-qyyp and the originator product. The package included data from the comparative phase 3 REFLECTIONS B327-02 trial that showed clinical equivalence between the biosimilar and trastuzumab for first-line treatment of approximately 500 patients from more than 20 countries with HER2-overexpressing metastatic breast cancer.
Adverse events commonly associated with trastuzumab-qyyp and the originator product include fever, nausea, vomiting, infusion reactions, diarrhea, infections, cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts and muscle pain.