The Yomiuri Shimbun OSAKA — The Japanese subsidiary of major British drugmaker AstraZeneca said it has applied to the government for approval of a drug for treating hereditary ovarian cancer (see below).
The Osaka-based subsidiary’s application, made for Olaparib (the generic name), is the first in the nation for a drug to treat hereditary cancers, which develop due to genes inherited from parents.
Its approval would increase the treatment options available to patients. However, there are concerns regarding the treatment process because family members of patients could learn that they are also at risk of developing the disease.
Academic societies related to the drug have begun discussions on establishing an appropriate treatment system, including how to support family members.
Olaparib is an oral medicine for patients who have mutations in their BRCA1 or BRCA2 genes, and who are suffering from a recurrence of hereditary ovarian cancer. The drug was approved in the United States and Europe in late 2014.
According to the subsidiary, it completed the domestic application process by the end of July, and the drug could be approved as soon as early next year.
Olaparib is said to have fewer side effects than conventional anticancer agents because it directly works against cancer cells. The Osaka-based company conducted a global joint clinical trial starting in 2013, and patients from Japan also took part.
The trial’s patients, who suffered from a recurrence of hereditary ovarian cancer, were divided into groups: one comprising 196 patients who took Olaparib, and the other comprising 99 patients who did not.
According to the trial, the patients belonging to the first group did not see growth in their cancer for an average of 19.1 months — nearly four times longer than those in the second group. No prominent side effects were confirmed during the testing.
Patients must undergo a genetic test to determine whether they are eligible for Olaparib treatment. If a patient tests positive, it means that their family members could also have the same mutation of BRCA genes.
Daisuke Aoki, vice chair of the Japan Society of Gynecologic Oncology, said: “By training doctors of gynecologic oncology, we would like to disseminate appropriate methods for informing patients [about the treatment] that pay proper attention to heredity aspects. We also want to call for the improvement of the counseling system regarding genetic inheritance.”
■ Hereditary ovarian cancer
Ovarian cancer developed by people who were born with mutations in either their BRCA1 or BRCA2 genes. About 10,000 people newly develop ovarian cancer each year, and about 10 percent of those cases are hereditary. The degree of malignancy is higher, and the progress of the tumor is faster.Speech