AZ/MSD’s Lynparza assigned Orphan status in US

AstraZeneca and MSD’s PARP inhibitor Lynparza has been granted orphan drug designation in the US for the treatment of pancreatic cancer.

Pancreatic cancer accounts for around 3% of all cancers in the US. Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease, and so five-year survival rates in the country remain bleak at just 8.5%.

"Pancreatic cancer is an area of significant unmet medical need. This is especially true for patients with metastatic disease where the benefits of current treatment options are very limited," noted Sean Bohen, executive vice president, Global Medicines Development, and chief medical officer at AZ.

"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," added Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, at MSD Research Laboratories.

The use of Lynparza (olaparib) in pancreatic cancer is being assessed in the ongoing Phase III POLO trial, which is testing the drug 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 next year, the firms said.

Lynparza is already approved for treatment of certain ovarian, fallopian tube, primary peritoneal and breast cancers, and is being investigated for a range of tumour types.

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