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AstraZeneca’s Lynparza granted orphan drug designation in Japan

Jose Baselga

Lynparza has been granted orphan drug designation (ODD) in Japan for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer.

Lynparza is co-developed and co-commercialised with MSD.

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

The POLO trial

The Phase III POLO trial showed Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in previous trials.

Lynparza was approved in the US as a 1st-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer in December 2019 with ongoing regulatory reviews in the EU and other jurisdictions.

Photo of José Baselga: AstraZeneca