FDA recommends no BLA submission based on IOB-013 trial data; new registrational study for Cylembio for the treatment of 1L melanoma planned
“We had a productive meeting with FDA; while this is not the outcome we had hoped for, we respect FDA’s feedback and remain confident in the therapeutic potential of Cylembio,” said Mai-Britt Zocca, PhD, president and chief executive officer of IO Biotech. “We look forward to continuing the dialogue with FDA to align on the design for a potential new registrational study. Additionally, we plan to discuss the data from our IOB-013 study with European regulators and determine a path to submission in the EU.”
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