Fast Track designation is designed to facilitate the development of, and expedite the review of, drugs intended to treat serious conditions and fill unmet patient needs. This designation comes alongside a variety of incentives, including Rolling Review, eligibility for Priority Review and Accelerated Approval, and more frequent meetings and communication with the FDA. According to Healio, the FDA recently granted Fast Track designation to ofranergene obadenovec, in conjunction with paclitaxel, for platinum-resistant advanced ovarian cancer.
Ofranergene Obadenovec: An Overview
Developed by VBL Therapeutics, ofranergene obadenovec (formerly VB-111) previously received Fast Track designation for another indication: glioblastoma.
CancerConnect explains how ofranergene obadenovec works:
Ofranergene disrupts the blood supply to the cancer by preventing new blood vessel growth (angiogenesis) and [ofranergene obadenovec] includes a replication deficient adenovirus 5 which then distributes the promoter and the transgene targeted to angiogenic blood vessels, leading to targeted endothelial cell death. In addition, in response to viral infection, immune-stimulating cytokines bring immune cells into the tumor and the neo-antigens produced by apoptosis are thought to further stimulate the anti-tumor response.
So far, the therapy has shown promise in early clinical studies. Over 300 individuals with solid tumors enrolled. The study found that the treatment was safe, effective, and well-tolerated. Currently, 409 patients are enrolled in a Phase 3 clinical trial evaluating ofranergene obadenovec for advanced ovarian cancer with paclitaxel. Data from the study should be available at the start of next year.
About Ovarian Cancer
As the name suggests, ovarian cancer forms in the ovary, one of two almond-shaped organs that store eggs and produces estrogen and progesterone. In Stage I ovarian cancer, the cancer may be found in one or both ovaries. As the cancer progresses, it may spread to the pelvis, abdomen, or other areas of the body such as the lungs or liver. There are four subtypes of ovarian cancer: epithelial tumors, stromal carcinoma tumors, germ cell carcinoma tumors, and small cell carcinoma of the ovary. In many cases, doctors do not know what causes ovarian cancer. However, there is a subset of cases caused by BRCA gene mutations. In fact, these mutations make females 10-30x more likely to develop ovarian cancer.
Symptoms associated with ovarian cancer can include:
- Pelvic pain
- Breast tenderness
- Appetite loss
- Changes in urinary urgency or frequency
- Abdominal distention
- Abnormal bleeding or vaginal secretions
- Endometrial hyperplasia
- Menstrual irregularities
Learn more about ovarian cancer.