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FDA Grants Priority Review to Tibsovo for Acute Myeloid Leukemia Subgroup
February 20th 2019The Food and Drug Administration granted a priority review to Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who are not eligible for standard therapy.
FGFR3 Inhibitor Shows Promise in Advanced Bladder Cancer
February 20th 2019Vofatamab (B-701) may be safe and effective for patients with locally advanced or metastatic bladder cancer with an FGFR3 mutation who have relapsed after, or are refractory to, at least one prior line of chemotherapy, according to preliminary findings.
FDA Grants Priority Review to Antibody Drug Conjugate for Diffuse Large B-Cell Lymphoma
February 19th 2019The Food and Drug Administration granted a priority review to polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
FDA Grants Priority Review to Entrectinib for Two Treatment Indications
February 19th 2019The Food and Drug Administration (FDA) granted a priority review to entrectinib for the treatment of adult and pediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors and for metastatic, ROS1-positive non-small cell lung cancer.