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Olaparib Takes Key Regulatory Step Toward Japanese Approval in Pancreatic Cancer

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Olaparib (Lynparza) has received an orphan drug designation in Japan for the maintenance treatment of germline BRCA-mutated curatively unresectable pancreatic cancer, according to AstraZeneca and Merck (MSD), the codevelopers of the PARP inhibitor.

The designation, which will expedite the development and review of olaparib in Japan for this indication, is based on data from the phase III POLO trial, which showed a progression-free survival (PFS) benefit with olaparib compared with placebo in this setting. Read more . . . 

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