Ikena Oncology’s Novel Cancer Treatment Receives Fast Track Designation from FDA
Ikena Oncology, a targeted oncology company, has announced that its novel aryl hydrocarbon receptor (AHR) antagonist, IK-175, has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The treatment will be used in combination with immune checkpoint inhibitors for patients with advanced urothelial carcinoma who have progressed on or within three months of receiving the last dose of checkpoint inhibitors.
Fast Track designation is given to therapies that have the potential to be the best-in-class therapeutic options for diseases with high unmet need. Therapies that receive Fast Track designation often have the opportunity to communicate more frequently with the FDA on trial design and data and may also be eligible for priority review.
“We are thrilled to receive Fast Track designation for IK-175 in combination with immune checkpoint inhibitors for patients with advanced urothelial carcinoma,” said Steve Kelsey, CEO of Ikena Oncology. “This designation underscores the significant unmet need in this patient population and the potential of IK-175 to address this need.”
Urothelial carcinoma is a type of cancer that affects the bladder, ureters, and renal pelvis. It is the sixth most common cancer in the United States, with an estimated 83,730 new cases and 17,200 deaths in 2021.
Ikena Oncology is a clinical-stage biotechnology company that is focused on developing targeted cancer therapies. The company’s pipeline includes several novel compounds that target key cancer pathways, including the AHR pathway, which is involved in the regulation of immune responses and cancer cell growth.
