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
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.

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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.