CTI files appeal on FDA Decision on Pixantrone NDA
CTI had requested accelerated approval of its Pixantrone NDA for a patient group for which there are no drugs currently approved in this clinical setting. The Office of
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eli Lilly and Company’s (Lilly) olomorasib as a potential treatment for adults with advanced pancreatic cancer who have already received at least one prior systemic therapy.