Janssen Submits sBLA to FDA for Darzalex Faspro in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant

Jan 31, 2024 08:12 CST Updated 08:12

Johnson & Johnson

Healthcare Product Manufacturers, Health Service Providers

On January 30, Johnson & Johnson announced that it had submitted to the FDADaratumumab Subcutaneous Injection Formulation (Trade Name:Darzalex Faspro）TheSupplemental Biologics License Application (sBLA) for use in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) asSuitable for acceptanceAutologous Stem Cell Transplantation（ASCT）TheNewly Diagnosed Adult Patients with Multiple MyelomaInduction therapy and consolidation therapy, followed by the combination of lenalidomide (D-R) as maintenance therapy for such patients.

This sBLA is primarily based on the positive results of the Phase III PERSEUS study. The study isA randomized, open-label clinical trial (709) evaluated the efficacy and safety of D-VRd and VRd as induction and consolidation treatments followed by D-R and lenalidomide (R) as maintenance therapy.ResearchThe primary endpoint isPFS。

Preliminary analysis results show that the patient receivedD-VRd as induction and consolidation therapy followed by D-R as maintenance therapy,The risk of disease progression or death was reduced by 58% (HR=0.42; 95% CI: 0.30-0.59; P<0.0001). Compared with receivingVRdAs induction therapy and consolidation therapy and then RAs a patient undergoing maintenance therapy,The degree of response, complete response rate (CRR), stringent complete response rate (sCRR), and minimal residual disease (MRD) negativity rate in patients from the D-VRd+D-R group were allHigher。

PERSEUS Study Efficacy Data (Source: NEJM)

In terms of safety,DaratumumabAnti-groupThere is34 patientsDeath. The most common adverse events were neutropenia (62.1%) and thrombocytopenia (29.1%). The incidence of serious adverse events was 57.0%.

Daratumumab is the world's first approved CD38 monoclonal antibody, which can directly bind to CD38, an important immunotherapy target on the surface of myeloma cells. It induces myeloma cell death through multiple mechanisms, achieving rapid therapeutic relief.