Darzalex Combination Receives Approval for First-Line Treatment of Patients with Multiple Myeloma Eligible for Transplant

Web Exclusives - FDA Updates, In the News, Multiple Myeloma

On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.

This approval was based on data from the open-label, randomized, phase 3 CASSIOPEIA clinical trial, which compared induction and consolidation treatment with daratumumab plus bortezomib, thalidomide, and dexamethasone (DVTd) versus bortezomib, thalidomide, and dexamethasone (VTd) in newly diagnosed patients with multiple myeloma who were candidates for ASCT.

Results showed that the addition of daratumumab to VTd led to a 53% reduction in the risk of progression or death compared with VTd alone (hazard ratio, 0.47; 95% confidence interval, 0.33-0.67; P <.0001). The stringent complete response rate 100 days post-ASCT was 28.9% in the DVTd arm versus 20.3% in the VTd arm. At a median follow-up of 18.8 months, the median progression-free survival had not been reached in either arm.

The most common (≥20%) adverse reactions in patients who received DVTd were infusion reactions, peripheral sensory neuropathy, constipation, asthenia, nausea, peripheral edema, neutropenia, thrombocytopenia, pyrexia, and paresthesia.

The recommended daratumumab dose is 16 mg/kg of actual body weight.

Related Items
2020 Year in Review - Multiple Myeloma
2020 Year in Review - Multiple Myeloma published on November 28, 2020 in Multiple Myeloma
Gavreto, RET Inhibitor, FDA Approved for Metastatic NSCLC with RET Fusions
Web Exclusives published on November 16, 2020 in FDA Updates
FDA NEWS: November 2020
TOP - November 2020 Vol 13, No 6 published on November 9, 2020 in FDA Updates
FDA News: September 2020
TOP - September 2020 Vol 13, No 5 published on September 14, 2020 in FDA Updates
CAR T-Cell Therapy Shows Deep, Durable Responses in Relapsed or Refractory Multiple Myeloma
Charlie Dawson
TOP - September 2020 Vol 13, No 5 published on September 14, 2020 in Multiple Myeloma
Bortezomib, Lenalidomide, and Dexamethasone Remains Standard of Care for Initial Treatment of Patients with Newly Diagnosed Multiple Myeloma
Charlie Dawson
TOP - September 2020 Vol 13, No 5 published on September 14, 2020 in Multiple Myeloma
FDA News: July 2020
TOP - July 2020, Vol 13, No 4 published on July 15, 2020 in FDA Updates
Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
Web Exclusives published on June 22, 2020 in FDA Updates, Lung Cancer
Opdivo Approved for Advanced Esophageal Squamous-Cell Carcinoma
Web Exclusives published on June 22, 2020 in FDA Updates
FDA Approves Cyramza plus Tarceva for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
Web Exclusives published on June 8, 2020 in FDA Updates, Lung Cancer
Last modified: April 27, 2020