The United States (US) Food and Drug Administration (FDA) has approved marstacimab-hncq, an anti-tissue factor pathway inhibitor, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (HA) without factor VIII inhibitors or hemophilia B (HB) without factor IX inhibitors (neutralizing antibodies).¹ The approval was based on results from the phase 3 BASIS trial, which showed a reduction in the annualized bleeding rate (ABR) with marstacimab-hncq compared to on-demand treatment and routine prophylaxis in patients with HA or HB without inhibitors.^1,2

The United States (US) Food and Drug Administration (FDA) has approved the anti-CD38 monoclonal antibody, isatuximab-irfc, in combination with standard-of-care treatment for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for transplant.^1,2 The approval was based on results from the phase 3 IMROZ study which showed that isatuximab combined with bortezomib, lenalidomide, and dexamethasone (VRd) significantly enhanced progression-free survival (PFS) compared to standard-of-care in newly diagnosed adult patients ineligible for autologous stem cell transplant (ASCT).¹

Patients with multiple myeloma (MM) are highly susceptible to developing relapsed and refractory (RR) disease towards lenalidomide and proteasome inhibitors (PIs) and require new active treatments at relapse. As such, novel treatment options like isatuximab, a monoclonal antibody (mAb) that targets