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Indications:
Metastatic Breast Cancer (MBC)
KANJINTI 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 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 postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with KANJINTI. This indication is based on data from one Phase III trial which studied the use of KANJINTI in combination with anastrozole (see 3.1.2 Clinical / Efficacy Studies).
Experience with other aromatase inhibitors is limited.
Early Breast Cancer (EBC)
KANJINTI is indicated for the treatment of patients with HER2 positive early breast cancer.
- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 3.1).
- 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 KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 2.4 and 3.1).
KANJINTI should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Metastatic Gastric Cancer (MGC)
KANJINTI 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 gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
KANJINTI should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
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