FDA Approval Summary: Daratumumab for Treatment of Multiple Myeloma After One Prior Therapy

Abstract

Multiple myeloma is mostly an incurable disease. The U.S. Food and Drug Administration (FDA) granted daratumumab accelerated approval in November 2015 as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome and an immunomodulatory agent. This article describes the FDA review of the strength of evidence for this application and its clinical implications for the multiple myeloma population.

Isatuximab Plus Pomalidomide/Dexamethasone Versus Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma: Icaria Phase Iii Study Design

“…The shorter infusion time of ISA may also represent an advantage for patient convenience compared with DARA. In addition, DARA has recently been approved by the US FDA as a second-line treatment for RRMM, in combination with Len/dex or bortezomib/dex [50]. The ICARIA-MM study is the first study to investigate the efficacy of ISA in RRMM in a randomized Phase III trial.…”

PD-1/PD-L1 Blockade Therapy in Advanced Non-Small-Cell Lung Cancer: Current Status and Future Directions

“…Therapeutic monoclonal antibodies targeting PD‐1 or PD‐L1 have demonstrated notable clinical efficacy in the treatment of various advanced cancers . Up to the end of 2017, five monoclonal antibodies targeting PD‐1 or PD‐L1 have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of various advanced cancers (Table ), including melanoma , non‐small‐cell lung cancer (NSCLC) , head and neck squamous cell cancer , classical Hodgkin lymphoma , urothelial carcinoma , hepatocellular carcinoma , Merkel cell carcinoma , renal cell carcinoma , and colorectal cancer . Immune checkpoint therapy, which was first approved as second‐line treatment and has been extended to first‐line treatment , becomes an alternative option for cancer therapy.…”

Ninety-minute daratumumab infusion is safe in multiple myeloma

“…The incidence and severity of IRRs has led to the recommended administration rates which result in infusion times for the first, second and subsequent infusions of 6.5, 4.5 and 3.5 hours respectively[7]. To decrease the IRR rate, one trial tested the addition of 10 mg of montelukast as a premedication prior to the first daratumumab infusion and found the IRR rate was one-third lower in patients who received this leukotriene inhibitor[8].…”