On 19 September the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for daratumumab (Darzalex®, commercialised by Janssen). The new indication is a combination of daratumumab, bortezomib, lenalidomide and dexamethasone and it brings a significant benefit with respect to progression-free survival compared to the standard of care for transplantation-eligible patients with newly diagnosed multiple myeloma (induction therapy with bortezomib, lenalidomide, and dexamethasone (VRd) followed by autologous stem-cell transplantation, consolidation therapy with VRd, and maintenance therapy with lenalidomide) (source: Sonneveld et al. 2024). The decision was based on the results of the PERSEUS clinical trial. For more information on the PERSEUS trial please see the interview MPE conducted with one of its lead investigators here.

Daratumumab has several approved indications for multiple myeloma in Europe (in bold the new indication):

• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for newly diagnosed multiple myeloma ineligible for autologous stem cell transplant
• in combination with bortezomib, lenalidomide and dexamethasone for newly diagnosed multiple myeloma eligible for autologous stem cell transplant
• in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed multiple myeloma eligible for autologous stem cell transplant
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the patients who have received at least one prior therapy
• in combination with pomalidomide and dexamethasone for patients who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy
• as monotherapy for patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy

For the change to be implemented, the recommendation still needs the final decision of the European Commission.

For a reminder on daratumumab, please see MPE’s factsheet here.