The Food and Drug Administration (FDA) has recommended that ImmunoGen, Inc. conduct a new phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.
The Food and Drug Administration has approved Bavencio (avelumab; EMD Serono), a programmed death-ligand 1 (PD-L1) blocking antibody, in combination with Inlyta (axitinib; Pfizer), a kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The FDA has approved Cyramza (ramucirumab; Lilly) for use as a single agent in the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400ng/mL and have been treated with sorafenib.
This study validated the effectiveness of the NCCN Distress Thermometer and Problem List for Patients, validated tools for assessing distress in patients with cancer, for use in telephonic case management.
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.