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FDA Approves Fifth Trastuzumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Thursday, Jun 13, 2019

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.

References

  1. Trastuzumab-anns prescribing information. FDA. Published June 13, 2019. https://bit.ly/31yj2SY. Accessed June 13, 2019. 
  2. 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).
  3. 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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