FDA approves new treatment for advanced ovarian cancer
December 23, 2014
The U.S. Food and Drug Administration (FDA) has approved a new treatment for women with advanced and recurrent ovarian cancer who test positive for the BRCA gene mutation. The new therapy, olaparib, will be used to treat women who have already received three or more lines of chemotherapy.
The new therapy, which will be marketed under the name Lynparza, is a poly (ADP-ribose) polymerase – or PARP inhibitor – that hampers cancer cells’ ability to repair damaged DNA, potentially causing the cancer cells to die. Olaparib was approved along with a blood test called BRACAnalysis CDx that detects BRCA gene mutations in patients with ovarian cancer.
"The FDA approval of olaparib is a significant milestone for our patients as currently there are only limited treatment options available to women with ovarian cancer who carry the BRCA mutation," says Ursula Matulonis, MD, director of the Gynecologic Oncology Program at the Susan F. Smith Center for Women’s Cancers at Dana-Farber. Matulonis noted that the Gynecologic Oncology Program at Dana-Farber has been involved in olaparib clinical trials for ovarian cancer since 2007.
Olaparib was tested in a trial that included 137 ovarian cancer patients who carried the BRCA gene mutation. The results showed 34 percent of the patients responded to the drug, meaning the tumors partially shrunk or completely disappeared. The average response lasted for 7.9 months.
The FDA approved Olaparib under its accelerated approval program, which allows faster approval of a drug if it is used to treat a serious or life-threatening disease and clinical trial data shows that it is likely to benefit patients. Meanwhile, the company producing the drug, AstraZeneca, will continue to evaluate data from ongoing clinical trials to confirm the drug’s effectiveness and achieve full approval from the FDA.