The U.S. Food and Drug Administration (FDA) recently approved a new indication for the Darzalex Faspro combination developed by Johnson & Johnson's Janssen Biotech. This drug will be used in combination with bortezomib, lenalidomide, and dexamethasone (VRd), specifically for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation (ASCT).

This approval is based on the results of the CEPHEUS (NCT03652064) trial, an open-label, randomized, active-controlled clinical trial. The trial subjects were newly diagnosed multiple myeloma patients who were ineligible for ASCT treatment due to various reasons or refused ASCT as an initial treatment option. However, the FDA also noted that the efficacy of Johnson & Johnson's Darzalex Faspro-VRd for patients who refuse ASCT as initial treatment has not been fully established.

In the trial, a total of 395 patients were randomly assigned, with 197 receiving the Johnson & Johnson Darzalex Faspro-VRd combination therapy and 198 receiving VRd monotherapy. The primary efficacy evaluation endpoints included the overall minimal residual disease (MRD) negativity rate and progression-free survival (PFS) as assessed by an independent review committee based on the International Myeloma Working Group response criteria. The results showed that the MRD negativity rate in the Johnson & Johnson Darzalex Faspro-VRd group reached 52.3%, significantly higher than the 34.8% in the VRd group. Meanwhile, the PFS hazard ratio was 0.60, demonstrating the advantage of Johnson & Johnson's Darzalex Faspro-VRd in prolonging patients' progression-free survival.