According to a story from Cure Today, the biopharmaceutical company Ambrx Biopharma, Inc., recently announced that the US Food and Drug Administration (FDA) has given Fast Track designation to the company’s investigational treatment ARX517, which is being developed to treat metastatic castration-resistant prostate cancer. The drug is currently being tested in a phase 1/2 clinical trial with around 150 patients.
About Prostate Cancer
Prostate cancer occurs in the prostate gland, part of the male reproductive system that is positioned beneath the bladder. Risk factors for prostate cancer include old age, a family history of the disease, and being of African ancestry. Tumors can appear on the prostate as cells accumulate DNA mutations, but most do not become cancerous. In early stages, prostate cancer doesn’t cause symptoms, but as the disease progresses, difficulty urinating, erectile dysfunction, and bloody urine or semen can appear. Fatigue, bone or back pain, or unexpected weight loss are signs of metastatic disease. Treatment for prostate cancer can vary widely depending on risk and severity of the individual case. Options can include surgical removal of the prostate, hormone therapy, or radiation therapy. Chemotherapy is often used when the disease has spread. Due to screening programs, prostate cancer is often detected at an early stage, and in these cases, patients can have relatively long survival times after diagnosis. To learn more about prostate cancer, click here.
About Fast Track Designation
Fast Track designation is a special designation from the FDA which is intended to accelerate the development and review of drugs that are intended to address serious conditions and meet an urgent, unmet medical need. This is defined as treating a condition that has no approved treatment but may also apply if the drug in question appears to demonstrate superiority over current therapies. A therapy that receives Fast Track designation is also potentially eligible for several benefits, such as more frequent interactions with the FDA in the form of meetings and written communication, Priority Review and Accelerated Approval (if other criteria are satisfied), and Rolling Review, which allows the developer to submit portions of its New Drug Application as they are completed, rather than having to wait until every section is finished. Fast Track is requested by the developing company.
