FDA Roundup: September 20, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA and NIH announced “Advancing Smoking Cessation: FDA and NIH Priorities” – a joint public meeting focused on advancing innovation of smoking cessation products to help both adults and youth. The meeting will be held October 21, 2024, and will feature presentations and panel discussions on several smoking cessation-focused topics, as well as an opportunity for public comment on several topics related to cessation.
• On Thursday, the FDA approved Zenrelia (ilunocitinib tablets), a new animal drug used to control pruritus (itching) associated with allergic dermatitis and to control atopic dermatitis (environmental allergies) in dogs at least 1 year of age.

  Zenrelia is safe and effective when used according to the label. However, the product labeling carries a boxed warning stating that dogs should not be vaccinated at least 28 days before and after treatment with Zenrelia, due to the risk of fatal vaccine-induced disease and inadequate immune response to vaccines.

• On Thursday, the FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. Full prescribing information for Rybrevant will be posted on Drugs@FDA. 
• On Wednesday, the FDA’s Center for Veterinary Medicine announced that it is supporting a collaborative agreement to the Reagan-Udall Foundation for the FDA to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis. This SWOT analysis aims to research the challenges within, and unmet needs of, the animal health, animal food and veterinary industries, and explain the economic impact of these gaps.
• On Wednesday, the FDA’s Center for Veterinary Medicine announced the establishment of four Animal and Veterinary Innovation Centers (AVICs) and recipients of funding for work to advance regulatory science and further development of innovative products and approaches to better support animal health and veterinary interventions. These AVICs further the goals outlined in the FDA’s Animal and Veterinary Innovation Agenda (AVIA), which describes the agency’s plans to spur innovation to better protect human and animal health. The three areas of concentration for the AVICs focus on:
  • Highly Pathogenic Avian Influenza (HPAI) and emerging zoonotic disease threats or One Health issues; 
  • Intentional genomic alternations (IGAs) in animals and the advancement of regulatory science in this field, with a focus on IGAs that support agricultural resilience, food security, animal health, or public health; and 
  • Unmet veterinary medical needs in both minor and major species that create a significant animal or public health burden.
• On Wednesday, the FDA updated the outbreak advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies to include additional cases.
• On Tuesday, the FDA approved Kisqali (ribociclib) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. Additionally, the FDA also approved the Kisqali Femara Co-Pack (ribociclib and letrozole co-pack,) for the same indication. Full prescribing information for Kisqali and Kisqali Femara Co-Pack will be posted on Drugs@FDA. 
• On Tuesday, the FDA approved Keytruda (pembrolizumab) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Full prescribing information for Keytruda will be posted on Drugs@FDA.

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