The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab (Herceptin) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.1
In March, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for ABP 980 to treat patients with HER2-positive metastatic breast cancer, HER2-positive early breast cancer, and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
- Trastuzumab-anns prescribing information. FDA. Published June 13, 2019. https://bit.ly/31yj2SY. Accessed June 13, 2019.
- Kolberg HC, Tomasevic Z, Demetriou G, et al. Efficacy analyses of central laboratory pCR results from the LILAC study comparing the biosimilar ABP 980 and trastuzumab. J Clin Oncol 2018;36 (suppl; abstr 583).
- von Minckwitz G, Ponomarova O, Morales S, et al. Efficacy and safety of biosimilar ABP 980 compared with trastuzumab in HER2-positive early breast cancer. In: Proceedings from the 2017 ESMO Congress; September 8-12, 2017; Madrid, Spain. Abstract 151PD.
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