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All Oncology News

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

The European Medicines Agency has validated a Marketing Authorization Application for belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor, and a CD38-directed monoclonal antibody.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.

The European Medicines Agency has validated a Marketing Authorization Application for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have received ≥2 prior anti-HER2 treatment regimens.