Drugs

FDA Flags BeOne Tevimbra Promotional Materials

CDER’s Office of Prescription Drug Promotion (OPDP) has issued BeOne Medicines USA an untitled letter over its promotional materials for cancer immunotherapy Tevimbra (tislelizumab-jsgr), citing omissions of risk information and an overly broad portrayal of the drug’s approved uses. FDA says said it reviewed two branded Microsoft Teams background images submitted under Form FDA 2253 and determined they misbrand Tevimbra.

According to the letter, the backgrounds featured claims such as “BRINGING MORE TO THE TABLE IN UPPER GI CANCERS” and “APPROVED IN CERTAIN UPPER GI CANCERS,” paired with imagery suggesting the upper digestive tract. Regulators say those claims constitute promotional representations about the drug’s use and benefits and therefore must be accompanied by risk information. The materials included no safety disclosures, which FDA says creates a misleading impression of the product’s safety profile.

FDA also faulted the materials for failing to adequately communicate Tevimbra’s full FDA-approved indications. While the backgrounds broadly referenced “upper GI cancers,” the drug is approved only for specific settings: certain esophageal squamous cell carcinomas and PD-L1–positive gastric or gastroesophageal junction adenocarcinomas, either in defined combinations with chemotherapy or as a single agent after prior treatment. By not specifying those limitations, the agency notes, the materials could lead viewers to infer broader approved uses than allowed.

The agency requested that BeOne take immediate corrective action, including ceasing dissemination of the materials, and submit a written response within 15 working days detailing all similar promotions and a plan to discontinue them.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome