FDA Roundup: August 11, 2023

SILVER SPRING, Md., Aug. 11, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA issued an Outbreak Advisory for an investigation of Listeria monocytogenes potentially linked to ice cream. The FDA advises consumers, restaurants, and retailers not to eat, sell, or serve recalled Real Kosher Ice Cream Soft Serve On The Go ice cream cups. The FDA's investigation is ongoing and updates to the advisory will be provided as they become available.
  
  
• On Thursday, the FDA published a CDER Conversation where Theresa Mullin, PhD, Associate Center Director for CDER's Strategic Initiatives, talks about CDER's important work in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The FDA engages with other regulatory and industry stakeholders worldwide to harmonize regulatory requirements across regions. A major part of the FDA's regulatory harmonization effort is undertaken through our work as a Founding Regulatory Member of the ICH providing leadership of key committees and expert working groups, developing harmonized guidelines and related training, and providing expert feedback on guideline development.
  
  
• On Wednesday, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The prescribing information for talquetamab-tgvs has a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Because of the risks of CRS and neurologic toxicity, including ICANS, talquetamab-tgvs is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the Tecvayli-Talvey REMS. View full prescribing information for Talvey.
  
  
• On Wednesday, the FDA approved pralsetinib (Gavreto, Genentech, Inc.) for adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Pralsetinib was previously granted accelerated approval for the NSCLC indication on Sept. 4, 2020, based on initial overall response rate and duration of response in 114 patients enrolled in the ARROW trial (NCT03037385), a multicenter, open-label, multi-cohort trial. The conversion to regular approval was based on data from an additional 123 patients and 25 months of additional follow-up to assess durability of response. The most common adverse reactions (≥ 25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. View full prescribing information for Gavreto.
  
  
• On Monday, the FDA cleared the V-PRO maX 2 Low Temperature Sterilization System for the sterilization of 3D printed devices in health care facilities. This is the first FDA-cleared sterilization system with a specialty cycle that can effectively sterilize surgical instruments such as patient-specific surgical guides (e.g., osteotomy, shoulder, hip, knee, and spine) and anatomical models that are fabricated via 3D printing processes and that are intended for single-use during operative procedures.

Additional Resources: 

• FDA Newsroom 

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Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 

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SOURCE U.S. Food and Drug Administration