Click Here to
Subscribe
Breaking
News, Updates,
& More
Stay Up
to Date

FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma

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

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
November 11, 2019 — Oncology News & Updates
Web Exclusives published on November 11, 2019 in FDA Updates, In the News
Zejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer
Web Exclusives published on November 7, 2019 in FDA Updates, Ovarian Cancer
November 4, 2019 — Oncology News & Updates
Web Exclusives published on November 5, 2019 in Financial Toxicity, Head and Neck Cancer, Hematologic Cancers, In the News, Leukemia
Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer
Web Exclusives published on October 29, 2019 in FDA Updates
Turalio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor
Web Exclusives published on October 29, 2019 in FDA Updates
Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors
Web Exclusives published on October 29, 2019 in FDA Updates
October 28, 2019 – Oncology News & Updates
Web Exclusives published on October 28, 2019 in FDA Updates, In the News, Ovarian Cancer
Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
Web Exclusives published on October 22, 2019 in Breast Cancer, FDA Updates, In the News, Multiple Myeloma, Pediatric Cancer
FDA on In Vitro Diagnostics, Vaping; Cost of Novel Treatments
Web Exclusives published on October 15, 2019 in FDA Updates, In the News, NCCN
Polivy FDA Approved for Patients with Relapsed or Refractory DLBCL
Web Exclusives published on September 11, 2019 in FDA Updates, Lymphoma
Last modified: September 30, 2019