The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.
The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.
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