FDA approves Trazimera biosimilar to Herceptin to treat breast and gastric cancers
The FDA has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), 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 Trazimera and the originator product. This includes results from the REFLECTIONS B327-02 clinical comparative study that was recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between Trazimera and the originator product in patients with first line HER2 overexpressing metastatic breast cancer.
See- Pegram MD, Bondarenko I, Zorzetto MMC, et al. "PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomized, double-blind study". Brit J Cancer. 2019;120:172-182. doi: 10.1038/s41416-018-0340-2.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins