Johnson & Johnson announced the US Food and Drug Administration (FDA) approval of the drug combination Tecvayli and Darzalex Faspro for adult patients with relapsed or refractory multiple myeloma (RRMM).[1][2] This combination is intended for patients who have already completed previous treatment. The approval is based on the results of the phase III MajesTEC-3 study, which demonstrated a significant improvement in progression-free survival and overall survival compared to standard treatment in second-line therapy.[4][5][7] The combination of Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) is the first off-the-shelf immunotherapy to achieve these results in relapsed patients.[5] Tecvayli is a bispecific T-cell engager targeting BCMA, while Darzalex Faspro is an anti-CD38 antibody.[2][4] The safety profile of the combination corresponds to the profile of individual drugs in monotherapy.[4] These drugs are already approved in Europe for various indications in multiple myeloma.[5]