Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA2 pathogenic variants status confers therapeutic sensitivity to Niraparib in patients with Peritoneal Serous Carcinoma.
The U.S. Food and Drug Administration granted approval to niraparib for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Niraparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for niraparib.
This statement is based on a regulatory approval from the Food and Drug Administration:
ZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.