Sotorasib’s Confirmatory Data in NSCLC Unreliable, Says FDA Panel
An FDA advisory committee on Thursday said the confirmatory trial data for the KRAS inhibitor sotorasib (Lumakras) in previously treated non-small cell lung cancer (NSCLC) cannot be reliably interpreted in the CodeBreaK 200 study. Most members of the Oncologic Drugs Advisory Committee (ODAC) agreed with FDA staff that multiple sources of systemic bias during the […]
FDA Panel Endorses DFMO for Kids’ High-Risk Neuroblastoma in Remission
After wrangling all day over semantics and a potential precedent-setting dataset, an FDA advisory committee voted to recommend approval of eflornithine (difluoromethylornithine; DFMO) maintenance for high-risk pediatric neuroblastoma in complete remission after standard therapy. By a 14-6 vote, the Oncologic Drugs Advisory Committee (ODAC) decided that the totality of evidence presented was sufficient to show […]
FDA Advisors Grapple With Logistical, Ethical Issues of Artificial Womb Technology
While members of the FDA Pediatric Advisory Committee (PAC) said much of the existing artificial womb technology (AWT) research is promising, they noted that the logistical and ethical concerns previously raised by the agency’s staff members are complicated. The committee did not vote during their 2-day meeting this week. Further discussion about first-in-human trials for […]
CDC Advisors Support Updated COVID Shots for All
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 in favor of recommending updated, monovalent, XBB-targeting COVID-19 shots for everyone age 6 months and up. Specifically, the language in the recommendation supports the “2023-2024” vaccines as authorized or approved by the FDA — in order to cover the recently green-lighted mRNA shots, […]
CDC Advisors Back Therapeutic to Prevent RSV in Infants
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV). At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first […]
Senate Committee Advances Pandemic Preparedness Legislation
The Senate Health, Education, Labor & Pensions (HELP) Committee voted 17-3 with relatively little fanfare Thursday to send pandemic preparedness legislation to the full Senate for a vote. “I don’t think any of us will ever forget we have lost over a million Americans from COVID,” Sen. Bernie Sanders (I-Vt.), chair of the HELP Committee, […]
ACIP Endorses 20-Valent Pneumococcal Vaccine for Kids
The CDC’s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children. All 14 members voted in favor of the following four proposals: Routine use in children ages 2-23 months: ACIP recommended either the 15-valent PCV (PCV15; Vaxneuvance) or PCV20, […]
FDA Panel Endorses mAb to Prevent RSV in Infants
An FDA advisory committee on Thursday gave strong backing to a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age. In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the […]
Antibody for Infant RSV Prevention to Face FDA Panel
An FDA advisory committee on Thursday will consider whether to recommend a shot of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease in both infants and in at-risk children up to age 2 years. The Antimicrobial Drugs Advisory Committee will examine a biologics license application approval for nirsevimab, a […]
Thumbs Down From FDA Panel on Plastic Meniscus Replacement
An FDA advisory committee voted 6-2, with one absention, that a novel, synthetic knee meniscus replacement’s benefits do not outweigh its risks, and thus is not suitable for marketing. Members of the Orthopaedic and Rehabilitation Devices Panel of the FDA’s Medical Devices Advisory Committee said the efficacy data were too weak, and a nearly 50% […]