Indications : התוויות

4.1     Therapeutic indications

Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.

Zirabev in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.

Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.

Zirabev, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. (see section 5.1).

Zirabev in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and/or metastatic renal cell cancer.

Zirabev, as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.

Zirabev, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking). (see section 5.1).

Zirabev, in combination with carboplatin and gemcitabine is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.

Zirabev in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. (see section 5.1).

Zirabev, in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix. (see section 5.1).