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 approves elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory myeloma
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.
Janssen seeks European marketing authorisation for subcutaneous (under the skin) daratumumab (Darzalex®)
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.
Lenalidomide and pomalidomide based triplet combination regimens for myeloma patients receives approval from the European Commission
The European Commission has approved two of Celgene’s IMiD ® -based combination regimens: Lenalidomide (Revlimid®) in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant Pomalidomide (Imnovid®) in combination with bortezomib and dexamethasone (PVd), in adult patients with multiple myeloma, who have received at least one prior treatment regimen including lenalidomide.
Myeloma Patients Europe (MPE) has launched a Central and Eastern Europe (CEE) Workgroup on Access during our recent Annual General Meeting (AGM) in Munich, Germany. The Workgroup is chaired by MPE board members, Kristina Modic, also CEO of our Slovenian member Slovensko Združenje Bolnikov Z Limfomom In Levkemijo L&L, and Biba Dodeva, President of our Macedonian member BORKA. It was launched in response to an identified need for coordinated action at a European level on…
Shortages of essential cancer medicines have a direct impact on patient care across Europe. To ensure that this issue remains a top priority on the EU policy agenda, the European Society for Medical Oncology (ESMO) collaborated with the European Parliament to organise a cross-partisan event entitled “Shortages of Inexpensive, Essential Medicines: Calling for Tangible Political Commitments in the EU”, according to a press release sent by ESMO today.