Rubraca Granted Accelerated FDA Approval for Advanced BRCA-positive Ovarian Cancer
Rubraca has been shown to lead to complete or partial reduction of the tumor in 54% of women over 9.2 months, according to a press statement.
Rubraca (rucaparib) received accelerated approval by the U.S. Food and Drug Administration for the treatment of patients with BRCA-positive ovarian cancer that have already received 2 or more chemotherapies.1
It is estimated that over 22,000 women were diagnosed with ovarian cancer in 2016 and about 15% to 20% of these will have the BRCA gene mutation.1
Rubraca, a PARP inhibitor, was developed by researchers at Newcastle University and has been shown to lead to complete or partial reduction of the tumor in 54% of women over an average of 9.2 months, according to a press statement. PARP inhibitors target the tumors cell's DNA repair mechanisms leading to cell death without affecting healthy cells.2Yvette Drew, MBBS, MRCP, PhD, a senior lecturer at Newcastle University and honorary consultant in medical oncology at Newcastle upon Tyne Hospitals NHS Foundation Trust who helped lead the clinical development of Rubraca said in a press release, “Rubraca is a well-tolerated oral drug, allowing women to have a better quality of life for longer without debilitating side effects that are often seen with chemotherapy. The approval of this medication is a great achievement for the Newcastle University team and is an example of what can be achieved when scientists and oncologists work together to target a specific type of cancer at the molecular level.”2
1. FDA grants accelerated approval to new treatment for advanced ovarian cancer [news release]. Silver Spring, MD: FDA Website; December 19, 2016. www.fda.gov/newsevents/newsroom/pressannouncements/ucm533873.htm. Accessed April 23, 2017.
1. Ovarian cancer patients get access to life-extending drug [news release]. United Kingdom: Newcastle University Press Office; April 7, 2017. www.ncl.ac.uk/press/news/2017/04/rubracafadapproval/. Accessed April 23, 2017.