Zuhera Indications/Uses

Breast Cancer: Metastatic Breast Cancer (MBC): Zuhera is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2: a) As monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease; b) In combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease; c) In combination with an aromatase inhibitor for the treatment of patients with hormone-receptor-positive metastatic breast cancer.
Early Breast Cancer (EBC): Zuhera is indicated for the treatment of adult patients with HER2-positive early breast cancer: Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable); Following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin; In combination with neoadjuvant chemotherapy followed by adjuvant Zuhera, for locally advanced (including inflammatory) breast cancer or tumors >2 cm in diameter.
Metastatic Gastric Cancer (MGC): Zuhera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Zuhera should be used in only those MGC patients whose tumours overexpress HER2, as defined by immunohistochemistry (IHC2+) and a confirmatory silver in situ hybridisation (SISH) or fluorescence in situ hybridisation (FISH) result, OR by an IHC 3+ result. Accurate and validated assay methods should be used.