According to a story from Benzinga, the drug developers AstraZeneca and Merck have recently announced that the US Food and Drug Administration (FDA) has decided to accept a supplemental New Drug Application (NDA) for the cancer drug Lynparza. This application would be for priority review for the drug as a treatment for BRCA mutated ovarian cancer in patients that were recently diagnosed and had displayed partial to complete response after treatment with platinum-based chemotherapy.
About Ovarian Cancer
Ovarian cancer can appear on or within the ovary. Ovarian cancer rarely causes distinctive symptoms in its early stages, so many patients are often diagnosed with advanced disease. The risk of getting ovarian cancer is connected to how long a woman has ovulated during her life; women who ovulate for longer periods are at greater risk. Late menopause or early puberty are risk factors, as are not having children, fertility medication, certain genetic variants and mutations (such as BRCA mutations), and exposure to talc, herbicides, and pesticides. Some symptoms of ovarian cancer include fatigue, bloating, a feeling of fullness, loss of appetite, indigestion, abdominal swelling, and pelvic pain. Treatment can include chemo, radiation, surgery, hormone therapy, and immunotherapy. There are many different kinds of ovarian cancer. Five year survival rate is 45 percent in the US. To learn more about ovarian cancer, click here.
Lynparza is a part of class of highly precise and targeted cancer therapies called PARP inhibitors. This class of drugs has been developed specifically to treat cancers that have been linked to BRCA mutations; these mutations drastically increase the risk of ovarian cancer and breast cancer. Tumors with BRCA mutations utilize the PARP pathway as a way to repair damage to their DNA. Inhibiting this pathway prevents the tumor cells from repairing their DNA, ultimately killing them.
This NDA submission is rooted in data from a Phase 3 clinical trial of Lynparza in which the drug was shown to reduce the risk of death or cancer progression by 70 percent in patients with newly diagnosed platinum sensitive BRCA mutated ovarian cancer. Approval in this new indication will allow a greater number of patients with this disease to have access to Lynparza sooner than they otherwise would.