Lynparza Granted Orphan Drug Status for Pancreatic Cancer
The FDA grants ODD status to drugs intended for the treatment, diagnosis or prevention of rare diseases or disorders.
Lynparza (olaparib; AstraZeneca and Merck) has been granted Orphan Drug designation for the treatment of pancreatic cancer by the Food and Drug Administration (FDA).
Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, is being assessed in the ongoing Phase 3 POLO trial. The study includes 145 patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following first-line platinum-based chemotherapy. Patients were randomized to receive Lynparza (300mg twice daily) as a maintenance monotherapy or placebo; the primary endpoint is progression-free survival. Results are expected in the first half of 2019.
Lynparza is currently FDA-approved as a maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy, and for certain advanced ovarian and breast cancers.
For more information visit Merck.com.