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.
CAR-T-cell treatment is thought to be one of the most promising therapies in development for the treatment of myeloma. There are several ongoing clinical trials evaluating the safety and efficacy of CAR-T-cells, and some of the studies with very encouraging results.
It is with great sadness that we share that our friend, colleague, and fellow patient advocate, Anna Rovira, passed away during the night of the 26 January 2021 after a short but very intense battle against cancer.
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.