The U.S. Food and Drug Administration (FDA) approved the first drug from a new class to treat ovarian cancer, as well as a test to identify patients eligible to receive the drug.
Before the FDA approved the drug Lynparza (olaparib) it was clinically tested on just less than 140 patients with BRCA mutation-associated ovarian cancer, according to an FDA-issued news release. Of the patients participating, 34 percent experienced partial shrinkage or complete disappearance of their ovary tumors for an average of eight months.
Lynparza is believed to help treat ovarian cancer, which forms on a woman's ovary, one of a pair of female reproductive glands where ova, or eggs, are formed. The drug targets the BRCA gene that, when healthy, repairs damaged DNA and suppresses tumor growth.
The most common candidate for the new drug is a woman who received extensive treatment for advanced ovarian cancer associated with defective BRCA genes, according to the news release. Candidates for the drug will be chosen if they pass a gene test to confirm BRCA gene mutations. The test was approved by the FDA to be used in conjunction with the drug.
"Today's approval constitutes the first of a new class of drugs for treating ovarian cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in the news release. "Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment."
