EMA CHMP gives positive opinion on CAR-T treatment idecabtagene vicleucel (Abecma) in earlier lines of therapy for relapsed and refractory myeloma

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has given a positive recommendation for the extension of the marketing authorisation for idecabtagene vicleucel (ide-cel), a CAR-T treatment marketed by BMS as Abecma®. Ide-cel is currently approved for the treatment of patients with relapsed and refractory myeloma, who have received at least three previous lines of therapy. The extension means that ide-cel will now be indicated for the treatment…

EMA CHMP confirms recommendation for non-renewal of Blenrep marketing authorisation

The European Medicines Agency (the EU medicines regulator) Committee for Medicinal Products for Human Use (CHMP) has today confirmed their earlier recommendation to not renew marketing authorisation for belamaf mafadotin (Blenrep®). The confirmation follows a review of the CHMP decision, requested by the manufacturer GSK. MPE Co-Chief Executive Officer, Kate Morgan, commented: “The final recommendation from the EMA CHMP is a disappointing one. Whilst we understand the limitations from the DREAMM-3 clinical trial data, we…

The European Commission grants final approval for elranatamab for the treatment of relapsed or refractory myeloma

The European Commission has granted conditional marketing authorisation for elranatamab, also known as Elrexfio® marketed by the pharmaceutical company Pfizer. This follows an earlier positive recommendation from the European Medicines Agency (EMA – the EU drug licensing body) Committee for Medicinal Products for Human Use (CHMP), after which the European Commission had 60 days to ratify. The decision means that the product is safe and effective to prescribe in myeloma patients in the 27 EU…

MPE launches European Amyloidosis Diagnosis Pathway to promote early detection of the rare disease

Today, 26 October 2023, is World Amyloidosis Day, a day dedicated to raising awareness about the rare disease amyloidosis and the key issues and challenges for patients. A central theme for the day, organised by the Amyloidosis Alliance, alongside amyloidosis patient organisations from across the globe, is improving the diagnosis experience of patients. Amyloidosis is a group of rare, serious conditions caused by a build-up of an abnormal protein called amyloid in organs and tissues…

EMA CHMP gives positive recommendation to elranatamab for the treatment of relapsed or refractory myeloma

On October 12, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) gave positive recommendation for the conditional marketing authorisation of elranatamab, also known as Elrexfio. The treatment will be offered as a 40 mg/ml solution for injection. Its active component, elranatamab, is a bispecific monoclonal antibody that targets the CD3 receptor on T cells and BCMA on plasma cells, including those in malignant multiple myeloma. Elranatamab is…

A statement from MPE on the situation in Israel and Gaza

MPE and our community are extremely saddened by the ongoing and devastating events in Israel and Gaza. The death of hundreds of innocent people is completely unacceptable, and our deepest sympathy goes out to everyone affected. We know our members are continuing to provide support to patients and their families during this difficult time. All myeloma patients and caregivers in Israel who need support or have concerns should contact Varda Shoham from AMEN at:

EMA CHMP recommends non-renewal of marketing authorisation for Blenrep®

On September 15, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended non-renewal of marketing authorisation for belamaf mafadotin (Blenrep®).   Blenrep is currently approved for myeloma patients who have received at least four previous treatments and have stopped responding to at least one proteasome inhibitor (e.g., bortezomib), one immunomodulatory agent (e.g., lenalidomide), and an anti-CD38 monoclonal antibody (e.g., daratumumab), and whose cancer has worsened since…

EMA recommends expansion of melphalan flufenamide (Pepaxti®) marketing authorisation

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has granted a positive opinion on the application for an extended marketing authorisation (i.e. a license) for melphalan flufenamide (Pepaxti), also called melflufen.   Melflufen, in combination with dexamethasone,  is currently licenced in the EU for treating myeloma patients who have received at least three prior lines of therapy and are refractory to at least one proteasome inhibitor (such as…

European Commission approves talquetamab for the treatment of relapsed and refractory myeloma

The European Commission (EC) has granted conditional marketing approval to talquetamab (Talvey®) for the treatment of relapsed and refractory myeloma. These patients must have undergone at least three prior treatments, including an immunomodulatory agent (such as lenalidomide or pomalidomide), a proteasome inhibitor (such as bortezomib or carfilzomib), and an anti-CD38 antibody (such as daratumumab). Additionally, they must have demonstrated disease progression on their most recent therapy.   Talquetamab is a bispecific antibody which targets the…