Access to generic lenalidomide (e.g. Revlimid) in Europe

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Sandoz, a manufacturer of generic medicines, announced the launch of generic lenalidomide in 19 European countries. You can see the full press statement here.    Alternatively known under the branded name “Revlimid”, lenalidomide is a drug licensed and commonly used in the treatment of myeloma – in newly diagnosed, maintenance and relapsed settings.   Lenalidomide was first approved by the European Medicines Agency (EMA) in 2008 and has been solely marketed in Europe by Celgene…

Myeloma Patients Europe (MPE) relaunches Myeloma Access Atlas platform

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Myeloma Patients Europe (MPE) has today relaunched the Myeloma Access Atlas, an online platform designed to provide myeloma and AL amyloidosis patient advocates with the information and tools needed to work effectively on access issues. Explore the Platform here.   The Atlas provides country-specific and comparative information on European healthcare systems, including data on system performance and on access inequalities to myeloma treatments. The aim behind the data and tools provided is to identify, understand…

Daratumumab subcutaneous, first approved treatment for newly diagnosed AL amyloidosis in Europe

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  The European Commission (EC) has granted marketing authorisation for the expanded use of daratumumab (Darzalex®) subcutaneous (SC) formulation in two new indications. The first authorisation of these new indications is for the use of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe.

European Commission approves the second indication of isatuximab for relapsed multiple myeloma

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    The European Commission (EC) has approved isatuximab (Sarclisa®) in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. This marks the second EC approval of isatuximab in combination with a standard of care regimen in less than 12 months.

The FDA approves the first anti-BCMA CAR-T Cell Therapy for myeloma, idecabtagene vicleucel (Abecma)

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   CAR-T cell therapy is a promising therapy option under investigation for the treatment of myeloma.. Different products are being studied, many with preliminary results showing high rates of response. Up until now there have been no approved CAR-T products for myeloma, however, CAR-T is now a reality after the US Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma) as the first CAR-T cell therapy for treatment of relapsed/refractory myeloma.

Selinexor receives Conditional Marketing Authorisation in Europe for the treatment of relapsed and or refractory myeloma patients

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   The European Commission (EC) has granted conditional marketing authorization for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

The FDA approves melphalan flufenamide for patients with relapsed or refractory myeloma

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    The U.S. Food and Drug Administration (FDA) has approved melphalan flufenamide (PEPAXTO®), also known as melflufen, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Selinexor receives positive opinion from the EMA for the treatment of refractory myeloma

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  The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional approval for selinexor in combination with dexamethasone for the treatment of adult myeloma patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Daratumumab becomes the first FDA-approved treatment for patients with newly diagnosed light chain (AL) amyloidosis

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   The Food and Drug Administration (FDA) granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.), a subcutaneous formulation of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.