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(Alliance News) - AstraZeneca PLC on Thursday said Japan has granted an orphan drug designation to Lynparza as a treatment for pancreatic cancer.
Shares in Astra were down 1.0% at 6,634.00 pence in London in morning trading.
Lynparza is being co-developed and co-commercialised with US drug maker Merck & Co Inc.
The designation applies to Lynparza in metastatic pancreatic cancer - metastatic meaning the cancer has spread - that is BRCA mutated. BRCA mutations are associated with certain cancers.
Japan's Ministry of Health, Labour & Welfare grants orphan drug designation to those medicines intended to treat diseases affecting less than 50,000 patients in the country with a high unmet medical need.
Astra noted that pancreatic cancer currently "has the lowest survival rate of the most common cancers and is the only major cancer with a five-year survival rate below 10% in almost every country".
The designation was granted based on the phase 3 Polo trial, which found that Lynparza almost doubled the time in which patients lived without disease progression compared to placebo.
Jose Baselga, executive vice president of Research & Development Oncology as Astra, said: "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."
By Anna Farley; annafarley@alliancenews.com
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