Drugs

FDA Hits Altor Bio Over Promo Violations

FDA has issued an untitled letter to Altor BioScience, an indirect wholly owned subsidiary of ImmunityBio, alleging that promotional Web pages for bladder cancer drug Anktiva (nogapendekin alfa inbakicept-pmln) are false or misleading and violate federal law. In the just-posted letter, CDER’s Office of Prescription Drug Promotion (OPDP) said it found that both a healthcare provider and a consumer-facing Web page for Anktiva misbranded the drug by overstating evidence for long-term clinical benefits.

The agency said the promotional materials improperly suggested that the therapy reduced the need for cystectomy and improved disease-specific survival, despite a lack of adequate clinical evidence to support those claims. According to OPDP, the Web pages cited data showing that 84% of responding patients were “cystectomy free” at 36 months and that disease-specific overall survival at 36 months was 99%. The agency said those figures were extracted from updated results of the single-arm QUILT-3.032 study, which was not designed to establish improvements in time-to-event outcomes such as cystectomy avoidance or survival.

“Absent an appropriate comparator, it is not possible to determine if the observed effect is attributable to Anktiva or to other factors, such as the natural history of the disease,” OPDP wrote. It acknowledged that the Web pages included footnotes cautioning that the cystectomy and survival data were secondary endpoints from a single-arm study and should be interpreted carefully. However, the enforcement unit said those disclaimers did not sufficiently mitigate the overall misleading impression created by the promotional claims, adding that it had previously raised similar concerns in an untitled letter sent to Altor last September.

OPDP requested that Altor take immediate corrective action, including ceasing the dissemination of the cited materials, and submit a written response within 15 working days outlining how it plans to address the violations.

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