Two multiple myeloma blockbusters are teaming up—and both drugmakers are set to benefit.
The FDA late Thursday cleared a combination of Johnson & Johnson’s Darzalex, Amgen’s Kyprolis and the steroid dexamethasone—a regimen known as DKd for short—for patients who've already tried one to three previous therapies.
The cocktail scored approval for two dosing regimens, with options for administration once or twice weekly.
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Regulators based the OK in part on data from the Candor study, which last year showed that adding Darzalex to the already-approved Kd regimen could slash patients’ risk of disease progression or death by 37%.
The new combo represents a marriage of two major myeloma drug classes. Kyprolis is a proteasome inhibitor, while Darzalex was the first approved member of the red-hot CD38 class, which now also includes Sanofi’s Sarclisa.
"This expanded approval for Kyprolis demonstrates a leap forward in the treatment paradigm for this complex disease by combining two potent agents in their respective drug classes,” Amgen R&D chief David Reese said in a statement.
It also represents an opportunity for both therapies to ramp up sales. Kyprolis has seen a much-needed lift in that department since Kd snagged an FDA go-ahead back in early 2018; it passed the blockbuster threshold for the first time last year, netting $1.04 billion in sales.
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Darzalex, meanwhile, has blitzed its way into the market’s top ranks after debuting in 2015, turning in a $3 billion 2019 haul.
The J&J contender may soon have to fight off a rival for use alongside Kd, though. In June, Sanofi showed that adding Sarclisa to Kd could cut patients’ risk of disease progression or death by 47%.
“We believe Sarclisa has the potential to become the anti-CD38 of choice for the treatment of multiple myeloma,” the French drugmaker’s R&D Chief, John Reed, M.D., Ph.D., said in a statement at the time.