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FDA Approves New Targeted Agent for Acute Myeloid Leukemia
The FDA has approved enasidenib (Idhifa) for the treatment of relapsed or refractory IDH2-mutant acute myeloid leukemia.
FDA Panel Backs Trastuzumab Biosimilar
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.
FDA Approves Ipilimumab for Pediatric Melanoma
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.
Blinatumomab Gets Full FDA Approval for B-Cell Precursor ALL
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.
FDA Approves Immunotherapy for MSI-High or MMR-Deficient Tumors
The FDA has granted approval to pembrolizumab for pediatric and adult patients with microsatellite instability (MSI)-high or mismatch repair (MMR)-deficient solid tumors.
Pembrolizumab Gets New Indications in Advanced Cancer
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.
FDA Approves New First-Line Lung Cancer Treatment
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.
Avelumab Gets FDA Approval for Urothelial Carcinoma
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.
FDA Approves Durvalumab for Advanced Urothelial Carcinoma
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.
FDA Approves Regorafenib for Liver Cancer
The FDA has approved regorafenib (Stivarga) for the second-line treatment of hepatocellular carcinoma (HCC) for patients who have previously received sorafenib.