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Officials with the FDA have approved trastuzumab-qyyp (Trazimera, Pfizer), a biosimilar to trastuzumab (Herceptin), according to a press release.1
Trastuzumab is indicated for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The agency’s approval of trastuzumab-qyyp was based on data, including results from the REFLECTIONS B327-02 trial, that showed a high degree of similarity between trastuzumab-qyyp and the originator product. In the study, trastuzumab-qyyp showed clinical equivalence and no clinically meaningful differences compared with the reference product in patients with first-line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program, trastuzumab-qyyp has been studied in approximately 500 patients.1