July 1, 2019

Darzalex Approved for Newly Diagnosed Stem Cell Transplant Ineligible Multiple Myeloma Patients

By

Darzalex (daratumumab) in combination with Revlimid (lenalidomide)
and dexamethasone has been approved by the US Food and Drug Administration  for treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell transplant.

Approval was based on MAIA (NCT02252172), an open-label,
randomized (1:1), active-controlled phase 3 study, comparing dartumumab (16
mg/kg) in combination with lenalidomide and low-dose dexamethasone (DRd) to
lenalidomide and low-dose dexamethasone (Rd), in 737 patients with newly
diagnosed multiple myeloma who were ineligible for autologous stem cell
transplant.

The trial demonstrated an improvement in progression-free
survival (PFS) in the DRd arm compared with the Rd arm. The median PFS had not
been reached in the DRd arm and was 31.9 months in the Rd arm (HR 0.56; 95% CI:
0.43, 0.73; p<0.0001). The median time to response was 1.05 months
(range: 0.2 to 12.1 months) in the DRd group and 1.05 months (range: 0.3
to 15.3 months) in the Rd group. The median response duration had not been
reached in the DRd group and was 34.7 months (95% CI: 30.8, not estimable)
in the Rd group.

Daratumumab can cause severe and/or serious infusion reactions,
including anaphylactic reactions. Approximately half of all patients in
clinical trials experienced an infusion reaction. Patients should be pre‑medicated
with antihistamines, antipyretics and corticosteroids. Frequently monitor
patients during the entire infusion is recommended.

In newly diagnosed multiple myeloma patients who received
daratumumab in combination with lenalidomide and dexamethasone, the most
frequent (≥20%) adverse reactions 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.

Reference: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-multiple-myeloma-ineligible-autologous-stem-cell-transplant

Copyright © 2019 CancerConnect. All Rights Reserved.

Tags: 23andme, brca, Breast Cancer, genetic testing, Multiple Myeloma, News, Uncategorized