Hercessi FDA Approval History
Last updated by Judith Stewart, BPharm on April 30, 2024.
FDA Approved: Yes (First approved April 25, 2024)
Brand name: Hercessi
Generic name: trastuzumab-strf
Dosage form: for Injection
Company: Accord BioPharma, Inc.
Treatment for: Breast Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma
Hercessi (trastuzumab-strf) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
- Hercessi is indicated for:
• adjuvant treatment of 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.
• 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.
• 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. - Patients are selected for therapy based on assessment of HER2 protein overexpression or HER2 gene amplification in tumor specimens using an FDA-approved companion diagnostic.
- Hercessi is biosimilar to Herceptin and does not have an interchangeability designation.
- Hercessi is administered by intravenous infusion.
- FDA approval of Hercessi was based on analytical, pre-clinical, and clinical data, which showed that Hercessi was highly similar to Herceptin in terms of efficacy, safety, and quality.
- Warnings and precautions associated with Hercessi include exacerbation of chemotherapy-induced neutropenia.
- Common adverse reactions when used as an adjuvant treatment for breast cancer include headache, diarrhea, nausea, and chills.
Common adverse reactions with used as a treatment for metastatic breast cancer include fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
Common adverse reactions when used as a treatment for metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. - Hercessi is the sixth FDA-approved Herceptin biosimilar, following the approvals of Ogivri (trastuzumab-dkst) in 2017, Herzuma (trastuzumab-pkrb) in 2018, Ontruzant (trastuzumab-dttb) in 2019, Trazimera (trastuzumab-qyyp) in 2019, and Kanjinti (trastuzumab-anns) in 2019.
Development timeline for Hercessi
Further information
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