Johnson & Johnson multiple myeloma drug Darzalex hasn’t 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.
With the new approval, Darzalex now boasts six—two of which are in the first-line setting. Last May, the drug became the first-ever monoclonal antibody to score an approval in newly diagnosed patients when the FDA green-lighted it for use alongside Takeda’s Velcade and prednisone.
“The value of those combination regimens” in the front line is “critical … especially since patients can be more easily treated in the first-line setting and in subsequent settings become more difficult to treat,” Andree Amelsberg, M.D., Janssen VP of oncology medical affairs, said in an interview ahead of the approval.
Despite already having leapt ahead of competitors and registered blockbuster sales—Darzelex pulled in $2.62 billion in 2018—J&J isn’t planning to stop there. “We want it to be fairly universal that you use the drug with whatever regimen you end up choosing,” Peter Lebowitz, M.D., Ph.D., Janssen’s global therapeutic area head of oncology, said last December.