FDA Hits Arog Pharmaceuticals With Untitled Letter Over Promotional Tactics

The FDA issued an untitled letter to Arog Pharmaceuticals for promotional claims it made on a display booth and a webpage about an unapproved investigational new drug’s safety and efficacy.

The Dallas, Texas company’s display booth at the American Society of Hematology annual meeting suggested that the drug, Crenolanib (crenolanib besylate), can be used to treat FLT3-positive acute myeloid leukemia (AML) and AML in general despite not having FDA approval, the agency said.

Specifically, the booth indicated that Crenolanib is safe and effective for AML treatment when combined “with chemotherapy at full doses,” despite a lack of safety and efficacy data for Crenolanib, a lack of toxicity data for current chemotherapy regimens and issues regarding regimen tolerability, the CRL said.