By Michael Dabaie
Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. said Thursday that the U.S. Food and Drug Administration approved Darzalex in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The approval is based on results from a Phase 3 clinical study, which showed the combination regimen reduced the risk of disease progression or death by 44% in newly diagnosed patients who are transplant ineligible, Janssen said.
This is the sixth Darzalex FDA-approved use in multiple myeloma and the second for newly diagnosed patients, the company said.
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