U.S. FDA granted orphan drug designation to olaparib for the treatment of patients suffering with cancer of the pancreas. Olaparib (Lynparza, AstraZeneca) is a first-in-class poly ADP-ribose polymerase inhibitor that may exploit inefficiencies of DNA damage response pathway to sabotage cancer cells. In the randomized phase 3 POLO trial, olaparib is being assessed among patients with BRCA-mutated metastatic pancreatic cancer who have not undergone progression following first-line platinum-based chemotherapy.
Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca expressed his concern for the unmet needs of the patients suffering with pancreatic cancer. He voiced hopes for the patients with metastatic pancreatic disease, where the current treatment regimes offer much room for better clinical outcomes. Olaparib is indicated for germline BRCA-mutated, HER2-negative metastatic breast cancer with a previous history of chemotherapy; BRCA-mutated, advanced ovarian cancer with three or more chemotherapy schedules; and for the maintenance therapy in the cases of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose malignancies have responded, completely or partially, to chemotherapy.
Complete report can be read here