Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Olaparib in patients with Pancreatic Adenocarcinoma.
The U.S. Food and Drug Administration granted approval to olaparib for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. 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 for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.