Genmab/Novartis’ Arzerra Gets Unfavorable CHMP Opinion
Genmab A/S GNMSF announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rendered a negative opinion for Arzerra as a maintenance therapy for patients suffering from relapsed chronic lymphatic leukemia (CLL). Currently, Arzerra is approved in the EU in combination with Leukeran or Levact for the treatment of patients with CLL who have not received prior therapy and are not eligible for Fludara-based therapy. […]