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The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate for the treatment of adult patients with chronic immune thrombocytopenia who are refractory to other treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the antibody-drug conjugate polatuzumab vedotin for use in combination with bendamustine and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for a hematopoietic stem cell transplant.

Treatment with the selective ROCK2 inhibitor KD025 led to statistically significant overall response rates in patients with chronic graft-versus-host disease who have received ≥2 prior lines of systemic therapy.

Novel combinations of biologic therapies, third-generation TKIs, and chemotherapy could lead to significantly higher cure rates for adult patients with acute lymphoblastic leukemia, with a number of early stage studies already showing promising results, according to Hagop M. Kantarjian, MD, at the 37th Annual CFS®.

The FDA has approved a supplemental Biologics License Application for romiplostim, updating its label to include data demonstrating sustained platelet responses in adults with immune thrombocytopenia. Romiplostim is approved for the treatment of adult patients with newly diagnosed or persistent who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.