The U.S. Food and Drug Administration (FDA) questioned results concerning a new ovarian cancer drug manufactured by AstraZeneca.
Test results for the drug, named olaparib, showed that it could effectively reduce the risk of progression of the disease by up to 83 percent. But a review conducted by the federal agency doubted that the results of the test were entirely true.
Experts gathered on Wednesday to decide whether olaparib should be approved for market distribution or if additional data is needed to support its efficacy.
Olaparib was specifically created for women suffering from BRCA gene mutation, a hereditary condition which may account for 10 to 15 percent increased risk of developing ovarian cancer. The drug was tested on patients for seven months with a seven-month follow-up period.
According to the U.S. Centers for Disease Control and Prevention (CDC), about 20,000 women are diagnosed with ovarian cancer per year, making it the eighth most common type of cancer and fifth leading cause of death in the United States.
Reuters reported that olaparib, if approved by the FDA, would take the commercial name Lynparza, and be presented as a drug that blocks the active polymerase Poly (ADP-ribose) and the enzyme that works in cell repair, PARP.
The FDA's doubt reportedly stems from the manner in which the company conducted tests and analyzed data. AstraZeneca gathered their information from secondary sources such as archived blood samples, which affected the accuracy of the research results regarding the effectiveness of the treatment.
Data collected by the company allegedly showed there was no difference between survival rates recorded for both of the treatment arms.
