J&Js Darzalex pads blockbuster sales with another myeloma nod in new patients

Johnson and Johnson multiple myeloma drug Darzalex hasnt stopped rolling since hitting the market. After picking up its first nod in previously untreated patients last May, the drug added a second indication in new patients on Thursday—and its sixth overall. The FDA cleared the product in combination with Celgene’s Revlimid and dexamethasone for patients who aren’t eligible for stem cell transplants after the combination showed it could slash the risk of myeloma progression or death by 44% compared to treatment with Revlimid and dexamethasone alone. Together, the data “really represents a practice-changing moment,” Mark Wildgust, Ph.D., VP of global medical affairs for oncology at J&J’s Janssen unit, said at the time, predicting that the cocktail would become the new standard of care. “For those patients today whom hematologists would think about giving Rev-dex, you should really be using” Darzalex alongside the pair. “It’s very convincing,” he added. J&J presented those results, from a phase 3 study dubbed Maia, at December’s American Society of Hematology annual meeting, and the agency handed over a speedy OK after an examination under its Real-Time Oncology Review pilot program.

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