The FDA has expanded the indication for Tibsovo to include treatment of newly diagnosed acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for darolutamide (Bayer and Orion), an investigational treatment for non-metastatic castration-resistant prostate cancer (nmCRPC).
Lilly is working to establish an access program to provide Lartruvo to patients who wish to continue treatment.
The researchers enrolled 25 platinum-pretreated, immunotherapy-naïve patients with recurrent advanced epithelial ovarian cancer (EOC) for the trial.
