The Food and Drug Administration has granted several new Fast-Track designations:
The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.
The following are the new agents given the designation:
* AG-120 for the treatment of patients with acute myelogenous leukemia with an isocitrate dehydrogenase-1 (IDH1) mutation. AD-120 is a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein. The drug is currently being evaluated in a Phase I clinical trial for this indication and results are expected to be presented at the European Hematology Association Annual Congress this month, according to a news release from Agios Pharmaceuticals, the drug's manufacturer. In addition, a Phase III study to evaluate the drug for this indication is being planned to begin in 2016.
* Evofosfamide (previously named TH-302) for use in combination with gemcitabine for the treatment of patients with previously untreated metastatic or locally advanced resectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under the severe tumor hypoxic conditions typical of many solid tumors. The drug is currently in Phase III trials for this indication. The drug, being developed by Merck in collaboration with Threshold Pharmaceuticals, Inc., has also previously received Fast Track designation for use in combination with doxorubicin for the treatment of advanced soft tissue sarcoma.
* Sacituzumab govitecan for the treatment of patients with metastatic non-small cell lung cancer that has failed to respond to two prior lines of therapy, including targeting therapies such as ALK inhibitors, EFGR inhibitors, and PD-1 inhibitors. Sacituzumab govitecan is an antibody-drug conjugate that works by conjugating SN-38, the active metabolite of irinotecan. Updated results of the current clinical trial for the drug were expected to have been reported at the American Society of Clinical Oncology Annual Meeting, according to a news release from the drug's manufacturer, Immunomedics, Inc. Sacituzumab had previously received Fast-Track status for the treatment of patients with triple-negative breast cancer or small-cell lung cancer; and the drug has also received Orphan Drug designation for the treatment of patients with small-cell lung or pancreatic cancers (OT 2/10/15 issue).
* Cobiprostone for the prevention of oral mucositis in patients with head and neck cancer receiving concurrent radiation and chemotherapy. Cobiprostone is a locally acting chloride channel activator that works to stimulate and protect the mucosal barrier function. A proof-of-concept, Phase II study of cobiprostone for this indication is planned to be initiated by the end of the quarter, according to a news release from the manufacturer, Sucampo Pharmaceuticals, Inc., and the drug is also being developed for the treatment of the gastroesophageal reflux disease subtype of non-erosive reflux disease.