Pharmaceutical giant AstraZeneca is seeking the first regulatory approval in Japan for a drug that could treat people with hereditary cancer caused from specific gene mutations.
A spokeswoman for the drugmaker said Tuesday that the multinational company’s Japanese arm is seeking approval for its drug Olaparib, which acts against cancers in people with hereditary mutations in genes associated with breast and ovarian cancer.
The pending application is for use of the drug only for ovarian cancer patients who have relapsed, the spokeswoman said, adding that the company hopes to get the green light sometime in the first half of next year.
The drug was approved in the United States and the European Union in 2014.
Out of the roughly 10,000 ovarian cancer patients diagnosed in Japan each year, around 10 percent are believed to be hereditary. Those with mutations in genes called BRCA1 or BRCA2 are the most common victims of hereditary ovarian cancer.
According to a clinical trial AstraZeneca conducted on relapsed ovarian cancer patients with BRCA1 or BRCA2 mutations, the progression-free survival period — the length of time during and after treatment that a patient lives with the disease without it worsening — for those who took Olaparib was 19.1 months compared to 5.5 months for patients who took the placebo.
Hereditary breast and ovarian cancer patients often have family members with either disease and are often diagnosed with breast cancer before the age of 40, according to the National Cancer Center.
Data compiled by the institution shows that breast cancer is the most prevalent cancer among women in Japan, with around 70,000 being diagnosed every year. Around 5 percent to 10 percent of all breast cancer cases are considered hereditary.
The spokeswoman for AstraZeneca said Olaparib could also be used for relapsed breast cancer patients with BRCA mutations, and said the company aims to submit a request for its regulatory approval in Japan for treatment of such patients by the end of the year.
According to data obtained abroad, the risk of a woman getting breast cancer due to defective BRCA1 and BRCA2 genes is 6 to 12 times higher than others, while the risk of women with defective genes developing ovarian cancer is 8 to 60 times higher.
The recent death of popular television personality Mao Kobayashi from breast cancer has helped raise public awareness of the disease, while highlighting the difficulties patients’ family members face.
Kobayashi, who chronicled her battle with cancer on her blog, said she tested negative for BRCA1 and BRCA2 mutations. However, she wrote that until the discovery, her mother, a former breast cancer patient, had been blaming herself for potentially passing on the disease.
Kobayashi herself harbored similar fears when she was waiting for the test results, she said, fearing that if she tested positive, it could mean that her own daughter would be put at a higher level of risk.
Information from Kyodo added
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