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Kanjinti FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 1, 2019.

FDA Approved: Yes (First approved June 13, 2019)
Brand name: Kanjinti
Generic name: trastuzumab-anns
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Breast Cancer, Gastric Cancer

Kanjinti (trastuzumab-anns) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2 overexpressing breast cancer, and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Indications and Usage

  • Adjuvant Breast Cancer HER2 overexpressing node positive or node negative (ER/PR negative or with one 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
    • as a single agent following multi-modality anthracycline based therapy.
  • Metastatic Breast Cancer
    • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
    • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
  • Metastatic Gastric Cancer 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.
  • In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
  • Kanjinti is administered as an intravenous (IV) infusion.

Adverse Reactions

  • Adjuvant Breast Cancer - Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea, and chills.
  • Metastatic Breast Cancer - Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
  • Metastatic Gastric Cancer - Most common adverse reactions (≥ 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

Kanjinti (trastuzumab-anns) is the fifth FDA-approved trastuzumab biosimilar, following the approvals for Trazimera (trastuzumab-qyyp) in March 2019, Ontruzant (trastuzumab-dttb) in January 2019, Herzuma (trastuzumab-pkrb) in December 2018, and Ogivri (trastuzumab-dkst) in December 2017.

Development timeline for Kanjinti

Jun 13, 2019Approval FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.