FDA approves Kanjinti for breast cancer and gastric cancer
Amgen and Allergan plc announced that the FDA has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Kanjinti was proven to be highly similar to, and to have no clinically meaningful differences from, Herceptin based on a comprehensive totality of evidence which included extensive comparative analytical, pharmacokinetic and clinical data. At the time of approval, Kanjinti is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin.
Comment: In June 2018 Amgen received a complete response letter for its trastuzumab biosimilar of Herceptin from the FDA. This CRL marked the third Herceptin biosimilar that has been stalled by the FDA. These drugs have been more successful in Europe.
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