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Multiple Myeloma: Update Bulletin [December 2016]

Product Code:
Publication Date:
December 2016

Gain new KOL insights on the latest events that have the potential to impact the treatment landscape of multiple myeloma (MM). Topics covered include expert opinions on: Takeda receiving a recommendation for approval for Ninlaro (ixazomib; Takeda), in combination with Revlimid (lenalidomide; Celgene) and dexamethasone, from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP); Janssen Biotech applying to US and EU regulators for expanded use of Darzalex (daratumumab), in combination with Revlimid (lenalidomide) and dexamethasone, or Velcade (bortezomib) and dexamethasone, for the treatment of adult relapsed MM patients who have received at least one prior line of therapy; and Karyopharm Therapeutics announcing positive top-line results from the Phase IIb STORM clinical study for its lead candidate, selinexor (KPT-330), a first in class oral selective inhibitor of nuclear export (SINE), for the treatment of patients heavily pre-treated for MM.

Business Questions:

  • What do KOLs believe is the key reason behind the European Medicines Agency’s (EMA) decision to approve Takeda’s Ninlaro (ixazomib) following its rejection in May 2016; a more careful look at the data, political pressure, or both?
  • Do KOLs believe that Ninlaro’s safety and oral administration will be an advantage in driving adoption over Velcade, or will concerns about its efficacy slow uptake?
  • How is Ninlaro being used in the US, and where do EU KOLs predict it being used in the treatment of MM?
  • Will Janssen Biotech’s lifecycle management strategy for Daratumumab pay dividends and drive treating physicians to use Darzalex earlier and more broadly in the treatment of MM?
  • Why are KOLs split on whether or not Darzalex will become the standard of care in the treatment of multiple myeloma?
  • How influential will a sensible pricing and focused market access strategy be on the wider adoption of Darzalex
  • How impressed are KOLs with mid-stage date for Karyopharm’s selinexor, and has the STORM study provided enough evidence to support its use?


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