Skip to main content

Darzalex Combined with Revlimid and Dexamethasone New First-Line Regimen for Patients with Multiple Myeloma Ineligible for Transplant

August 2019, Vol 12, Special Issue: Payers' Perspectives In Oncology: ASCO 2019 Highlights - FDA Approvals

On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT). This approval was granted a priority review and used the Oncology Center of Excellence Real-Time Oncology Review program. This is the sixth indication for daratumumab in multiple myeloma and the second indication for newly diagnosed patients.

This latest approval was based on results of the randomized, open-label, multicenter phase 3 MAIA clinical trial of 737 patients with newly diagnosed multiple myeloma who were not candidates for high-dose chemotherapy and ASCT. The patients were randomized in a 1:1 ratio to daratumumab plus lenalidomide and dexamethasone or to lenalidomide and dexamethasone alone.

The addition of daratumumab showed improvement in progression-free survival (PFS). The median PFS had not been reached in the daratumumab arm versus 31.9 months in the lenalidomide plus dexamethasone arm (hazard ratio, 0.56; 95% confidence interval, 0.43-0.73; P <.0001). The addition of daratumumab also resulted in higher rates of complete response or better than with lenalidomide and dexamethasone alone (48% vs 25%, respectively) and overall response (93% vs 81%, respectively), as well as a higher rate of minimal residual disease negativity (24% vs 7%, respectively).

The most frequent (≥20%) adverse events associated with daratumumab-based therapy were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dyspnea, and cough.

Related Items
Directory of FDA Approvals, August Through December 2023
December 2023 Vol 16, Payers' Guide to FDA Updates published on January 26, 2024 in FDA Approvals
Iwilfin FDA Approved for Adults and Pediatric Patients with High-Risk Neuroblastoma
Web Exclusives published on January 16, 2024 in FDA Approvals
Welireg Now FDA Approved for Patients with Advanced Renal Cell Carcinoma
Web Exclusives published on January 16, 2024 in FDA Approvals
Ogsiveo First Treatment FDA Approved for Desmoid Tumors
Web Exclusives published on January 2, 2024 in FDA Approvals
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of Advanced Gastroesophageal Junction Adenocarcinoma
Web Exclusives published on December 18, 2023 in FDA Approvals
Last modified: August 30, 2021