Drugs

FDA Cites Cancer Drug Television Ad

FDA has issued an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug Brukinsa (zanubrutinib) was false or misleading. In the letter, CDER’s Office of Prescription Drug Promotion said the broadcast ad for Brukinsa misbranded the drug by creating an inaccurate impression of its safety profile and monitoring requirements. The agency cited the ad’s portrayal of a patient with chronic lymphocytic leukemia (CLL) traveling and enjoying physically demanding activities after starting treatment, concluding that the images suggested patients could maintain a normal, highly active lifestyle without adequately conveying the risks and clinical oversight associated with the therapy.

According to FDA, adverse reactions to Brukinsa are most likely to occur when patients begin treatment or when doses change, and patients are expected to see healthcare providers regularly to monitor effectiveness and side effects. By emphasizing patient autonomy and control, paired with visuals of mountain travel and family celebrations, the ad downplayed those risks and obligations, the agency said.

The FDA also faulted the advertisement’s “major statement” presentation, which is required to disclose key risk information. The agency said the ad failed to present risk information in a clear dual-modality format — using both audio and on-screen text simultaneously — and instead displayed incomplete or mismatched text during the spoken risk disclosures. In addition, FDA said emotionally compelling visuals during the major statement interfered with viewers’ ability to comprehend the safety information.

The letter requested that BeOne immediately address the violations, including halting dissemination of the promotional materials. The company has 15 working days to respond, identify other Brukinsa promotions with similar claims, and outline a plan to discontinue or correct them.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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