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AstraZeneca's Lynparza gets new orphan designation in Japan

By Josh White

Date: Thursday 19 Mar 2020

AstraZeneca's Lynparza gets new orphan designation in Japan

(Sharecast News) - AstraZeneca announced on Thursday that Lynparza, or 'olaparib', has been granted orphan drug designation in Japan for the maintenance treatment of germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic cancer.
The FTSE 100 pharmaceuticals giant said Lynparza was co-developed and co-commercialised with MSD.

It said the Japanese Ministry of Health, Labour and Welfare grants orphan drug designation to medicines intended for the treatment of diseases that affected fewer than 50,000 patients in Japan, and for which there was a high unmet medical need.

Pancreatic cancer had the lowest survival rate of the most common cancers, AstraZeneca explained, and was the only major cancer with a five-year survival rate below 10% in almost every country.

"Japan has the fifth-highest incidence of pancreatic cancer worldwide and patients have seen limited treatment advances over the last few decades," said executive vice-president of oncology research and development Jos? Baselga.

"This designation is an important step forward in bringing the first targeted medicine to biomarker-selected patients with advanced pancreatic cancer in Japan."

Roy Baynes, senior vice-president and head of global clinical development, and chief medical officer at MSD Research Laboratories, said a pancreatic cancer diagnosis was "devastating", with the companies committed to research it aiming to change the prognosis for patients.

"The POLO trial demonstrated that treatment with Lynparza extended time without disease progression or death in patients with germline BRCA-mutated metastatic pancreatic cancer and we are hopeful that we will be able to bring this treatment to patients in Japan soon."

AstraZeneca said the phase 3 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, compared to 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 United States as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer in December, with ongoing regulatory reviews in the European Union and other jurisdictions.

At 1336 GMT, shares in AstraZeneca were down 1.37% at 6,606p.

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