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Japan grants orphan drug designation to Lynparza for BRCA+ unresectable pancreatic cancer

Published on 19/03/20 at 12:50pm

AstraZeneca has confirmed that its PARP inhibitor Lynparza (olaparib) has been awarded orphan drug designation in Japan for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer.

The nation’s Ministry of Health, Labour and Welfare hands out the designation to therapies designed to treat conditions for which there are less than 50,000 patients in the country. The Ministry made this latest decision off the back of Phase 3 data showing that Lynparza doubled the rate of progression-free survival or death to a median of 7.4 months, compared to just 3.8 months with placebo.

AstraZeneca’s drug is co-developed and commercialised with MSD, and is designed to help address the unmet need in pancreatic cancer, a disease with the lowest survival rate of any common cancer and the only one which less than one in ten will survive for five years or more.

“Japan has the fifth-highest incidence of pancreatic cancer worldwide and patients have seen limited treatment advances over the last few decades,” commented José Baselga, Executive Vice President at R&D Oncology. “This designation is an important step forward in bringing the first targeted medicine to biomarker-selected patients with advanced pancreatic cancer in Japan.”

Matt Fellows

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