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AstraZeneca - US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer

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AstraZeneca - US FDA grants Lynparza Orphan Drug Designation for pancreatic cancer

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Postby idpickering » October 16th, 2018, 7:21 am

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer.

Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the US.i 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.ii Five-year survival rates remain low in the US at 8.5%.iii

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer said: "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


https://www.investegate.co.uk/astrazene ... 00101185E/

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