FDA Issues Nascent Biotech Untitled Letter for Website Claims

The FDA’s Office of Prescription Drug Promotion hit Nascent Biotech with an untitled letter over claims on its website for the investigational brain cancer drug Pritumumab.

The website claimed the human monoclonal antibody has cured a rare type of brain cancer and offers patients an overall survival rate of 25 to 30 percent, as opposed to standard therapy’s three percent, “demonstrating antibodies are safe and effective.” The agency took issue with these claims as it hasn’t approved the drug or confirmed its safety and effectiveness.

“These claims and presentations are extremely concerning given the lack of adequate safety and efficacy data for Pritumumab,” the agency said. “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.”

The agency noted the lack of treatment options for brain cancer — and pointed out that the benefit/risk profile for Pritumumab is not currently known. It also cited the firm for failing to explain on the website the treatment’s status as an unapproved, investigational new drug.