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Trastuzumab Biosimilar for HER2-Overexpressing Breast Cancer Approved by the FDA

By: Sarah Jackson
Posted: Wednesday, March 13, 2019

The U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to trastuzumab (Herceptin), for the treatment of HER2-overexpressing breast cancer.

The FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between trastuzumab-qyyp and the originator product. Included were results from the REFLECTIONS B327-02 clinical comparative study (ClinicalTrials.gov identifier NCT01989676), which were recently published by Pegram et al in the British Journal of Cancer. The trial findings showed clinical equivalence, with a high degree of similarity and no clinically meaningful differences between trastuzumab-qyyp and the originator. As part of the REFLECTIONS clinical trial program, trastuzumab-qyyp has been studied in nearly 500 patients and across more than 20 countries to date.

“Approximately 15% to 30% of breast cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients,” said Mark Pegram, MD, investigator on RELECTIONS B327-02, Associate Director for Clinical Research at the Stanford Comprehensive Cancer Institute and Director of the Breast Oncology Program at the Stanford Women’s Cancer Center. “With the availability of biosimilars like trastuzumab-qyyp in the United States, oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need.”

Trastuzumab-qyyp was also approved for use in the treatment of HER2-overexpressing breast cancer in the European Union in July 2018.



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