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The submission of a supplemental biologics license application seeking the approval of a Monday/Wednesday/Friday intramuscular dosing schedule for asparaginase erwinia chrysanthemi-rywn for use as a component of a multiagent chemotherapy regimen in patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to Escherichia coli–derived asparaginase has been submitted to the FDA.

Andreas Reiter, MD, of University Medicine Mannheim

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the current indication for avapritinib to include single-agent use in patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, or mast cell leukemia.