Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA2 oncogenic variants status confers therapeutic sensitivity to Bevacizumab, Olaparib in patients with Ovarian Epithelial Tumor.
The U.S. Food and Drug Administration granted approval to olaparib 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 a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Olaparib's product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
This statement is based on a regulatory approval from the Food and Drug Administration:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor 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 a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.