ZIRABEV- bevacizumab-bvzr_injection, solution
Indication: ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of: 1. 1 Limitations of Use 1. 5 o 1. 6 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: [see Clinical Studies (14. 2) ZIRABEV, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonen dashsquamous nonen dashsmall cell lung cancer (NSCLC). ZIRABEV is indicated for the treatment of recurrent glioblastoma (GBM) in adults. ZIRABEV, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 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. 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.
Manufacturer:
Pfizer Laboratories Div Pfizer Inc
LYNPARZA- olaparib_tablet, film coated
Indication: Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer BRCA 1. 1 BRCA 1. 1 Breast cancer BRCA 1. 1 gBRCA 1. 1 Pancreatic cancer gBRCA 1. 1 Prostate cancer 1. 1 BRCA BRCA 1. 1 Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA [see Dosage and Administration (2. 1) ] Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: BRCA Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2. 1) Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA [see Error! Hyperlink reference not valid. ] Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCA [ Dosage and Administration (2. 1) Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCA [see Dosage and Administration (2. 1) Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA [see Dosage and Administration (2. 1) Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2. 1) Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA BRCAm [see Error! Hyperlink reference not valid.
Manufacturer:
AstraZeneca Pharmaceuticals LP
ZEJULA- niraparib_tablet, film coated
Indication: ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: 1. 1 BRCA 1. 1 ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAmut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA [see Dosage and Administration (2.
Manufacturer:
GlaxoSmithKline LLC