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

Darzalex
Johnson & Johnson's Darzalex has won an FDA green-light to treat second-line multiple myeloma patients in combo with two standard-of-care regimens.

Out of the three new multiple myeloma therapies to win FDA approval last year, only Johnson & Johnson’s Darzalex was relegated to the back of the line, cleared for use only after three other regimens had fallen short. But no longer.

Monday, the FDA approved the med—in combination with the chemo drug dexamethasone and either Celgene’s Revlimid or Takeda’s Velcade—for patients who had received just one prior therapy. The green light opens up the med’s target population considerably, and it’ll bring in patients who tend to stay on therapy for longer periods of time, giving Darzalex two routes to sales growth.

The win comes as no surprise, following the “breakthrough” designation the agency handed J&J in July. But it’s still welcome news for the drugmaker, which will now be on more even footing with its next-gen rivals. As Darzalex did, Takeda’s Ninlaro, and AbbVie and Bristol-Myers Squibb’s Empliciti both won their initial FDA approvals last November, and regulators cleared each of those for use in second-line cocktails from the get-go.

Another myeloma treatment that Darzalex can now vie with: Amgen’s beleaguered Kyprolis. The therapy has been toiling since Amgen forked over $10 billion for maker Onyx back in 2013, only recently winning its own go-ahead in the second-line setting. And it may be stuck there for a while. In September, the Big Biotech announced its product had flubbed its first Phase III study in newly diagnosed patients.

In multiple myeloma, though, one med’s gain isn’t necessarily another med’s loss, Craig Tendler, Janssen VP of late-stage development and global medical affairs for oncology and hematology, pointed out in an interview at ASCO in June.  “Many of these patients will go through many of these regimens; the nature of this disease is multiple relapses,” he told FiercePharma, adding, "The more options you have, especially in upfront and high-risk patients … the more likely we’ll be able to achieve the outcomes.”

And Amgen and J&J are already looking to see whether they can pair their contenders in a second-line regimen of their own. Earlier this month, the pair announced they’d struck a clinical trial collaboration and supply agreement, and on Amgen’s Q3 conference call, R&D head Sean Harper noted that a Darzalex-Kyprolis-dexamethasone regimen could be “extremely attractive” to those patients who fail on meds such as Revlimid in the first-line setting.   

“I think that's an obvious place for us to look at that kind of combination therapy, and that's what we're focused on,” he said.