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The injectable formulation can cut administration time from two or more hours to just five minutes.
More than 80% of clinical trial participants experienced complete or partial remission.
Darzalex Faspro can be given by subcutaneous injection rather than IV infusion.
The approval is based on data from CASSIOPEIA, an open-label, randomized, active-controlled phase 3 study.
Darzalex in combination with lenalidomide and dexamethasone is for people who are ineligible for an autologous stem cell transplant.
An advanced study compared intravenous infusions and subcutaneous injections of the antibody treatment.
Four-drug regimen improves response in people being treated for the first time.
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