Biotech - STAT

news

Lynparza is not for lung cancer. Indications and Usage for Lynparza 1.1 First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1)]. Maintenance Treatment of Recurrent Ovarian Cancer Lynparza is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Advanced gBRCA-mutated Ovarian Cancer After 3 or More Lines of Chemotherapy Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious gBRCAmadvanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. [see Dosage and Administration (2.1)]. 1.4 Germline BRCA-mutated HER2-negative Metastatic Breast Cancer Lynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1)]. https://www.drugs.com/pro/lynparza.html