The FDA has approved a fixed combination of daunorubicin and cytarabine (Vyxeos) for the treatment of newly diagnosed therapy-related acute myeloid leukemia (AML) as well as AML with myelodysplasia-related changes.
The FDA has approved enasidenib (Idhifa) for the treatment of relapsed or refractory IDH2-mutant acute myeloid leukemia.
The FDA Oncologic Drugs Advisory Committee has unanimously voted to recommend approval of the trastuzumab biosimilar MYL-1401O for the treatment of HER2-positive breast cancer.
The FDA has expanded the approval of ipilimumab (Yervoy) to include the treatment of pediatric melanoma patients 12 years and older with unresectable or metastatic disease.
The FDA has expanded the approval of blinatumomab (Blincyto) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children.
The FDA has granted approval to pembrolizumab for pediatric and adult patients with microsatellite instability (MSI)-high or mismatch repair (MMR)-deficient solid tumors.
The FDA has granted approval to pembrolizumab (Keytruda) in the first- and second-line settings for the treatment of patients with locally advanced or metastatic urothelial carcinoma.
The FDA has approval pembrolizumab (Keytruda), in combination with chemotherapy, for the first-line treatment of patients with metastatic non-squamous non–small-cell lung cancer.
The FDA has granted accelerated approval to avelumab (Bavencio) for treating locally advanced or metastatic urothelial carcinoma patients whose disease progressed following treatment with platinum-containing chemotherapy.
The FDA has approved durvalumab (Imfinzi) for the treatment of patients with advanced urothelial carcinoma whose disease has progressed after treatment with platinum-containing chemotherapy.