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

    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)

   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

   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

    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

  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

   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.

The FDA approves belantamab mafodotin for relapsed or refractory myeloma

  The US Food and Drug Administration (FDA) has approved belantamab mafodotin (BLENREP) as a monotherapy treatment for adult patients with relapsed or refractory myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This…

Belantamab mafodotin receives positive opinion from the EMA for relapsed and refractory myeloma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

European Commission grants Marketing Authorisation for subcutaneous daratumumab for all approved intravenous daratumumab indications

  The European Commission (EC) has granted marketing authorisation for daratumumab (Darzalex®) subcutaneous (SC) formulation for the treatment of adult myeloma patients. Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.