Johnson & Johnson's Darzalex snags landmark myeloma approval in first-line patients

The new FDA approval for Darzalex is its fifth in multiple myeloma. (J&J)

Johnson & Johnson’s Darzalex just vaulted ahead of its myeloma competitors—and it has plenty of them.

Monday, the FDA greenlighted the drug—in combination with Takeda’s Velcade and prednisone—in first-line multiple myeloma patients who are transplant ineligible, making it the first monoclonal antibody to ring up an approval in newly diagnosed patients.

The go-ahead is no surprise, considering the stellar data J&J unveiled at December’s American Society of Hematology annual meeting. In a trial of front-line patients, at a median follow-up of 16.5 months, the Darzalex regimen cut the risk of disease progression or death by 50%.


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Darzalex has come a long way since its first approval back in late 2015, which came the same month Bristol-Myers Squibb’s Empliciti and Takeda’s Ninlaro picked up their own FDA blessings. The J&J product was initially cleared only for patients who had tried three prior treatments, and it snagged its second-line OK a year later.

RELATED: J&J's Darzalex leaps ahead in multiple myeloma lineup with new FDA approval

Meanwhile, the newest approval marks Darzalex’s fifth in myeloma—and the way J&J’s executives see it, there are plenty more to come, including in the front-line setting.

“What we’ve seen is that the drug seems to benefit with any regimens—with other IMiD-containing regimens, with proteasome regimens ... so our general view is that this is a mechanism that can improve on [results from] any established regimen,” Peter Lebowitz, Janssen’s global therapeutic area head of oncology, said in an interview at ASH.

The company’s Janssen unit is currently trialing the hot-shot drug in other front-line studies, one of which is examining Darzalex in combination with an IMid therapy and a proteasome inhibitor. “We want it to be fairly universal that you use the drug with whatever regimen you end up choosing,” Lebowitz said.

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