FDA Approves Trastuzumab-qyyp in HER2-Overexpressing Breast and Gastric Cancers
The U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
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. This includes results from the REFLECTIONS B327-02 clinical comparative study, which were recently published by Pegram et al in the British Journal of Cancer. The trial findings showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between trastuzumab-qyyp and the originator.
“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,” 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 European Union in July 2018 for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
About Trastuzumab-qyyp
Trastuzumab-qyyp is a monoclonal antibody biosimilar of the originator biologic medicine, trastuzumab, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. Trastuzumab-qyyp locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.
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.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
