FDA Fast Track Designation for AKY-1189

“Patients with locally advanced or metastatic urothelial cancer who progress on systemic therapies, such as PADCEV, have limited treatment options,” said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. “The granting of Fast Track designation affords us a unique opportunity to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of addressing this unmet medical need by bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer.”

Share:

More News

“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.