Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Paclitaxel, Pembrolizumab in patients with Ovarian Epithelial Tumor.
The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >= 1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.
This statement is based on a regulatory approval from the Food and Drug Administration:
KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS >= 1) as determined by an FDA-authorized test, and who have recieved one or two prior systemic treatment regimens.