1 INDICATIONS AND USAGE
ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of:
Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1)
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1)
Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer. (1.1)
Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2)
Recurrent glioblastoma in adults. (1.3)
Metastatic renal cell carcinoma in combination with interferon alfa. (1.4)
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan. (1.5)
Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
oin combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, for stage III or IV disease following initial surgical resection. (1.6)
oin combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens. (1.6)
oin combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by ZIRABEV as a single agent, for platinum-sensitive recurrent disease. (1.6)
1.1	Metastatic Colorectal Cancer
ZIRABEV, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).
ZIRABEV, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: ZIRABEV is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2)].
1.2	First-Line Non-Squamous Non-Small Cell Lung Cancer
ZIRABEV, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous nonsmall cell lung cancer (NSCLC).
1.3	Recurrent Glioblastoma
ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults.
1.4	Metastatic Renal Cell Carcinoma
ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).
1.5	Persistent, Recurrent, or Metastatic Cervical Cancer
ZIRABEV, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
1.6	Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
ZIRABEV, in combination with carboplatin and paclitaxel, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.
ZIRABEV, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
ZIRABEV, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by ZIRABEV as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.