US FDA grants Lynparza Orphan Drug Designation for Pancreatic Cancer
by Dr. C.H. Weaver M.D. 10/2018
The US Food and Drug Administration (FDA) today announced that they were granting orphan drug designation for Lynparza (olaparib) for the treatment of pancreatic cancer.
About Pancreatic Cancer
Pancreatic cancer is one of the deadliest forms of cancer and is projected to become the second leading cause of cancer death by 2020. Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and close to 37,000 die from the disease. The disease is often diagnosed at an advanced stage, treatment remains challenging, and new treatment approaches are required.
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of selected patients with ovarian, fallopian tube, or primary peritoneal cancer. The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Precision cancer medicines that target and inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy and are called PARP inhibitors. By blocking this enzyme, DNA inside the cancerous cells is less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.
The use of Lynparza in pancreatic cancer is being assessed in the ongoing Phase III POLO trial, which is testing Lynparza as maintenance monotherapy vs placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy. Results from the POLO trial are expected in the first half of 2019.
About the POLO Phase III trial
POLO is a Phase III, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of Lynparza tablets (300 mg twice daily) as maintenance monotherapy compared with placebo, in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy. The trial randomized 145 patients to receive Lynparza or placebo (3:2). The primary endpoint is progression-free survival.