Johnson & Johnson\u2019s Darzalex just vaulted ahead of its myeloma competitors\u2014and it has plenty of them.<\/p>\n
Monday, the FDA greenlighted the drug\u2014in combination with Takeda\u2019s Velcade and prednisone\u2014in first-line multiple myeloma patients who are transplant ineligible, making it the first monoclonal antibody to ring up an approval in newly diagnosed patients.<\/p>\n
The go-ahead is no surprise, considering the stellar data J&J unveiled at December\u2019s 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%.<\/p>\n
Darzalex has come a long way since its first approval back in late 2015, which came the same month Bristol-Myers Squibb\u2019s Empliciti and Takeda\u2019s 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.<\/p>\n
Meanwhile, the newest approval marks Darzalex\u2019s fifth in myeloma\u2014and the way J&J\u2019s executives see it, there are plenty more to come, including in the front-line setting.<\/p>\n
\u201cWhat we\u2019ve seen is that the drug seems to benefit with any regimens\u2014with 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,\u201d Peter Lebowitz, Janssen\u2019s global therapeutic area head of oncology, said in an interview at ASH.<\/p>\n
The company\u2019s 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. \u201cWe want it to be fairly universal that you use the drug with whatever regimen you end up choosing,\u201d Lebowitz said.
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