The FDA has taken umbrage with certain Incyte promotional claims related to its chronic graft-versus-host disease (cGVHD) treatment Niktimvo.
In an untitled letter published on April 24, the U.S. regulator pointed to a landing page for the Niktimvo website that claims: “Niktimvo may offer fast and lasting responses.”
But in its letter, the FDA said: “these claims and presentations suggest that Niktimvo provides greater benefits to patients with cGVHD than has been demonstrated.” The company’s claims “misleadingly suggest that patients will experience a ‘fast’ response to the drug, when this is not the case,” according to the FDA.
Further, Incyte’s claim that more than “half (60%) of the people who showed a response to Niktimvo continued to respond for at least 1 year” is misleading because it “does not include patients who experienced progression,” according to the FDA.
It’s a similar story for a claim on a “Responses” webpage, namely: “People achieved responses in multiple affected organs."
Again, when looking at the trial data, the FDA said the overall response measure was based on “assessment of cumulative response across all organs, not specific individual organs.”
This, too, “misleadingly inflates the perceived benefit of the drug,” the regulator said. On the same page, Incyte also said its drug “offered symptom improvement,” but the FDA said this was simply “not demonstrated” by its data.
As with all these letters, Incyte has 15 working days from receipt to address the agency’s concerns.
In its full-year financials for 2025, Incyte said it saw “strong uptake of Niktimvo” during the year, with its sales reaching $151.6 million. The anti-CSF-1R antibody was approved for cGVHD in August 2024. Analysts see the drug eventually hitting blockbuster status.