New Indication for Darzalex Approved by FDA

The FDA has approved an indication expansion for Darzalex (Daratumumab, Janssen). The CD38-directed cytolytic antibody is now approved to be used in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who are ineligible for autologous stem cell transplants. 

This approval is based upon the results of MAIA (NCT02252172), an open-label, randomized, active-contolled phase 3 study that compared dartumunmab in combination with lenalidomide and low-dose dexamethasone (DRd) to lenalidomide and low-dose dexamethasone (Rd) in 737 patients. Results from the trial indicate an improvement in progression-free survival (PFS) in the DRd arm compared to the Rd arm. 

• Median PFS: not reached in DRd, 31.9 months in RD 

• Median time to response : 1.05 months in both arms

• Median response duration: not reached in DRd, 34.7 months in Rd

According to prescribing infomraiton, daratumumab is to be administered after premedication with corticosteroids, antipyretics, and anthihistamines. The drug should be diluted and administered as an intravenous infusion. The recommended dose is 16 kg/mg actually body weight, followed by post-infusion medications. 

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Daratumumab is available in 100mg/mL and 400mg/20mL solutions in single-dose vials. 

Daratumumab is contraindicated for patients with a history of severe hypersensitivity to daratumumab or any components of its formulation. 

Prescribing information carries warnings of infusion interactions, interference with cross-matching and red blood cell antibody screening, neutropenia, and thrombocytopenia that may occur with use of daratumumab. 

Adverse events reported in all clinical trials include infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, bronchitis, pneumonia and upper respiratory tract infection.

Full Prescribing Information             Healthcare Professionals’ Site