FDA’s OPDP Sends Untitled Letter Over Promos for Unapproved Brain Cancer Treatment
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) on Friday released an untitled letter sent earlier this month to Santa Fe-based Nascent Biotech for improperly promoting pritumumab, an investigational new drug to treat brain cancer, on its website.The company promotes pritumumab as safe and effective for the purposes for which it is being investigated, with lines like: “Pritumumab has cured a rare form of brain cancer,” or, “After 5 years, patients treated with pritumumab have an overall survival rate of 25- 30%, compared to 3% standard therapy, demonstrating antibodies are safe and effective.”
Nascent has updated its website since receiving the letter to take out the five years of statistical information on overall survival rate.
“These claims and presentations are extremely concerning given the lack of adequate safety and efficacy data for Pritumumab,” FDA adds. “Similarly, the suggestion that Pritumumab has established efficacy and has ‘cured a rare form of brain cancer’ is especially troubling given that brain cancer in general is a disease associated with a poor prognosis (i.e., decreased overall survival).”
The agency also explained how the benefit/risk profile associated with the treatment is not currently known.
“The conclusions reflected in the above claims create a misleading impression regarding the safety and effectiveness of the product. These claims are concerning given the seriousness of this disease and the relatively few available treatment options,” the letter says.
OPDP letter
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