EMPOWERING MYELOMA ADVOCACY ACROSS EUROPE
As part of the educational programme planned to replace the Masterclass included in the MPE Annual General Meeting (AGM) 2020, which was cancelled due to the outbreak of the coronavirus infection, MPE is organising a Webinars series.
The U.S. Food and Drug Administration (FDA) has approved isatuximab-irfc (Sarclisa®) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.
The professional society for health economics and outcomes research, ISPOR, organises its annual meeting in Copenhagen, Denmark. From 2 to 6 November experts attending this meeting will debate value in healthcare beyond cost-containment and short-term interventions.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the drug daratumumab (Darzalex®, commercialised by Janssen).
European Commission (EC) has approved elotuzumab –marketed under the brand Empliciti by Bristol-Myers Squibb (BMS)– plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.
DREAMM-2, the pivotal open-label, randomised study of two doses of belantamab mafodotin has reported a clinically meaningful overall response rate (ORR) in relapsed myeloma patients.
The pharmaceutical company Janssen, who produce a range of myeloma medicines, have today announced their application to the European Medicines Agency (EMA) for a license extension for daratumumab. This license extension, if approved by the EMA, would allow the use of subcutaneous (under the skin) daratumumab (Darzalex®) in myeloma patients.
The pharmaceutical company Takeda announced that the Phase 3 TOURMALINE-AL1 clinical trial in patients with relapsed or refractory AL amyloidosis did not meet the first of two primary endpoints. Treatment with ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared to physician’s choice of standard of care regimens. As a result of this analysis, Takeda has decided to discontinue the trial.
