According to a story from Targeted Oncology, the US Food and Drug Administration (FDA) has granted Fast Track designation to the experimental drug OMP-305B83, also known as navicixiumab. This designation is as a treatment for high grade ovarian cancer, as well as peritoneal and fallopian tube cancer. The drug would be for patients that have received bevacizumab (marketed as Avastin) and/or three or more prior therapies.
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 this 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 this disease, click here.
About Fast Track Designation
Fast Track designation from the FDA is intended to speed up the rate of development for therapies that are designed to treat serious, life-threatening diseases that have the potential to satisfy a currently unmet medical need. Alternatively, a drug can earn this designation if it shows substantial advantages in safety or effectiveness in comparison to current treatments. Benefits of Fast Track designation include more frequent meetings and correspondence with the agency to facilitate development, potential eligibility for Priority Review and Accelerated Approval, and Rolling Review.
Navicixiumab has been tested in a phase 1a clinical trial to treat patients with drug-resistant solid tumors and is also being investigated in a phase 1b trial in combination with the drug paclitaxel in patients with extensively pretreated ovarian cancer. The drug is classed as an anti-DLL4/VEGF antibody.
In the phase 1a trial of 66 patients, 19 saw their cancer tumor reduce in size. 17 patients had stable disease and four saw a partial response to the drug. Of these four, three of them had ovarian cancer.