FDA Roundup: April 19, 2024

SILVER SPRING, Md., April 19, 2024 /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 posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the U.S. Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T cell immunotherapies.

These completed changes follow a safety communication posted by the FDA in November 2023, and reflect requirements detailed in notification letters issued by the FDA in January 2024, to all manufacturers of the products in this class necessitating an update to the Boxed Warning on the package insert to include new safety information on the serious risk of T cell malignancies, with serious outcomes, including hospitalization and death. The FDA also required related safety labeling changes to other sections of the USPI: Warnings and Precautions, Postmarketing Experience, Patient Counseling Information and Medication Guide.

On Thursday, the FDA approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Full prescribing information for Alecensa will be posted here.

On Thursday, the FDA shared updates on agency activities to better understand Per- and Polyfluoroalkyl Substances (PFAS) in the food supply, including testing results, continuing efforts to supplement our PFAS monitoring, and an updated analytical method to measure PFAS.

On Wednesday, the FDA’s Center for Devices and Radiological Health Center (CDRH) released two reports on medical device safety and innovation –core pillars that help protect and promote public health for all. The “CDRH 2024 Safety Report” and the “CDRH 2024 Innovation Report” provide summaries of CDRH’s accomplishments and look ahead to future initiatives.

“Our focus on safety and innovation stems from our vision to protect and promote the public health by helping to assure that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices,” said CDRH Director Dr. Jeff Shuren.

On Wednesday, the FDA issued an outbreak advisory for a multistate outbreak of Salmonella Typhimurium infections linked to Infinite Herbs-brand organic basil packed in 2.5-oz clamshell packaging and sold at Trader Joe’s stores in AL, CT, D.C., DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, PA, RI, SC, TN, VA, VT, and WI. Typhimurium infections linked to Infinite Herbs-brand organic basil packed in 2.5-oz clamshell packaging and sold at Trader Joe’s stores in AL, CT, D.C., DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, PA, RI, SC, TN, VA, VT, and WI.

On Wednesday, the FDA approved Lumicell Inc.’s Direct Visualization System, a combination product that is the first fluorescent imaging system to assist in the detection of cancerous tissue within the lumpectomy cavity following the removal of the primary specimen during breast conserving surgery. This product consists of an optical imaging agent Lumisight (the drug pegulicianine) that is administered to the patient via intravenous injection two to six hours before imaging and a fluorescence imaging system designed to capture emissions from the optical imaging agent.

On Wednesday, the FDA also approved Lumisight (pegulicianine) in adults with breast cancer to assist the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. Lumisight is a fluorescent imaging drug for use with the Lumicell Inc.’s Direct Visualization System that is administered in the form of an intravenous injection before surgery.

On Tuesday, Nature Medicine published a new commentary co-authored by the FDA’s Center for Tobacco Products Director Brian King, Ph.D., M.P.H., discussing considerations for healthcare providers around talking to adults about the relative risks of different tobacco products. The commentary reinforces that youth should not use any form of tobacco products. Among adults who smoke, it stresses the importance of using evidence-based cessation methods, including FDA-approved pharmacotherapies, as a first line treatment. For adults who smoke and have tried proven cessation methods with no success, medical providers may consider educating patients about the relative risks of tobacco products and the importance of switching completely to a lower-risk product in order to realize the full health benefit, and of not engaging in prolonged use of both products. In conjunction with this release, the FDA launched a new webpage aimed at educating the public about the relative risks of tobacco products.

On Tuesday, the FDA launched a new post-incident response web page about elevated lead levels in cinnamon, focused on post-incident surveillance, prevention, and compliance activities.

On Monday, the FDA issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. Ltd. for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick.” As a result, the company must not market or distribute these products in the United States or they risk FDA enforcement action.

Additional Resources: 

FDA Newsroom

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Media Contact: FDA Office of Media Affairs, 301-796-4540
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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, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration