Genetic testing is required to receive treatment
The Food and Drug Administration (FDA) has approved a new drug to treat advanced ovarian cancer, along with a test to identify patients eligible to receive it.
Lynparza belongs to a new class of drugs, poly ADP-ribose polymerase (PARP) inhibitors, designed for women who have already received extensive treatment for advanced ovarian cancer associated with defective BRCA genes.
“The approval constitutes the first of a new class of drugs for treating ovarian cancer,” Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a 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.”
Approval was based on a clinical trial of almost 140 women. Thirty-four percent of the patients on the drug had partial shrinkage or complete disappearance of their tumors for an average of eight months. Women must have genetic testing to confirm BRCA gene mutations before being treated with the new drug.
This year, nearly 22,000 American women will be diagnosed with ovarian cancer and more than 14,000 will die from the disease.