British drug major AstraZeneca (AZN.L, AZN) and Merck & Co., Inc., (MRK) announced Tuesday that they were granted orphan drug designation or ODD by the US Food and Drug Administration for Lynparza (olaparib) for the treatment of pancreatic cancer, a rare, life-threatening disease.
Lynparza (olaparib) was the first in class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
In July 2017, AstraZeneca and Merck announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types.
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.
The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, at MSD Research Laboratories, said: “The FDA granting Orphan Drug Designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need.”