The Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns; Amgen and Allergan), a biosimilar to Herceptin (trastuzumab; Genentech).

Kanjinti, a HER2/neu receptor antagonist, is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with 1 high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline based therapy.

In addition, it is approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.

Kanjinti is also approved for use in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

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The approval of Kanjinti was based on data from the phase 3 LILAC study which compared the efficacy and safety of the biosimilar to the reference product in patients with HER2-positive early breast cancer. Study results showed that the 2 drugs had similar efficacy and safety outcomes. In a press statement, the Companies noted that “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.”

Like the reference product, Kanjinti carries a Boxed Warning describing cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

Kanjinti will be supplied as 420mg lyophilized powder in a multiple-dose vial for reconstitution. Prior to treatment, HER2 testing using FDA-approved tests should be performed. The product should not be substituted for or with ado-trastuzumab emtansine.

For more information visit amgen.com.