Selinexor receives positive opinion from the EMA for the treatment of refractory myeloma

  The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional approval for selinexor in combination with dexamethasone for the treatment of adult myeloma patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Daratumumab becomes the first FDA-approved treatment for patients with newly diagnosed light chain (AL) amyloidosis

   The Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.), a subcutaneous formulation of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.