Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd aloneIf approved, it would represent the fourth indication in the EU and second in the front-line setting globally Paris, June 23, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use ( ...

ASCO: new Sarclisa data support subcutaneous administration with on-body injector New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusionStudies used Enable Injections’ enFuse® on-body injector, an automated hands-free injectorData will form the basis of global regulatory submissions across all currently approved lines of treatment P ...

GSK plc (GSK) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma.The CHMP recommended the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone for treating relapsed/refractory multiple myeloma in adult patients who have received at least one prior therapy. The ...