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Multiple Myeloma: Update Bulletin # 3

  • ID: 4792984
  • Report
  • March 2019
  • Region: Global
  • FirstWord Publishing
This edition presents key opinion leader (KOL) views on recent developments in the treatment of multiple myeloma (MM). Topics covered include KOL views on Karyopharm Therapeutics' submission, in January 2019, of a marketing authorisation application to the EMA with respect to selinexor (a first-in-class Selective Inhibitor of Nuclear Export therapy) for the treatment of penta-refractory MM; this follows the FDA's decision to delay approval pending further data. KOLs also give their views on the impact on clinical practice of the FDA's approval of a split-dose infusion regimen for the monoclonal antibody Darzalex (daratumumab; Johnson & Johnson). In addition, KOLs discuss Amgen's presentation, at the 60th American Society of Hematology (ASH) annual meeting, of data from a first-in-human study of the novel bispecific T-cell engager (BiTE) immunotherapy AMG 420, which targets B-cell maturation antigen (BCMA). Business Questions:

  • Karyopharm Therapeutics' SINE therapy, selinexor, is under regulatory review in Europe and the US for the treatment of penta-refractory MM; but how optimistic are KOLs regarding the use of selinexor in this setting?
  • Updated results from selinexor's Phase IIb STORM study were published in December 2018. How compelling are the reported efficacy data and could selinexor change the current treatment paradigm?
  • Does selinexor's side-effect profile give rise to any concerns that may present a barrier to usage of the drug in clinical practice?
  • In February 2019, the FDA approved a split-dosage regimen for Johnson & Johnson's monoclonal antibody Darzalex (daratumumab), but what are the advantages of administering Darzalex in this way?
  • Will the approval of split dosing for Darzalex result in wider uptake of the drug?
  • How warranted was the approval of a split-dosing regimen for Darzalex, given that Johnson & Johnson is currently developing a subcutaneous formulation of the drug?
  • Amgen is currently developing AMG 420, a novel bispecific T cell engager (BiTE). Following presentation of the first-in-human data at the 60th ASH annual meeting in December 2018, how optimistic are KOLs with regard to this innovative approach to treating rrMM?
  • How concerned are KOLs regarding the potential for treatment-related adverse events with AMG 420?
  • If approved, where in the current treatment paradigm will AMG 420 be used?
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