- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Friday, the FDA approved Medtronic’s Aurora EV-ICD System for the treatment of patients who have experienced, or are at significant risk of developing, life-threatening abnormally fast heart rhythms (ventricular tachyarrhythmias). The system is composed of the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and the Epsila EV MRI SureScan EV2401 Extravascular lead for the delivery of anti-tachycardia pacing therapies, cardioversion, or defibrillation therapies to treat abnormal heart rhythms.
- On Friday, the FDA granted accelerated approval to entrectinib (Rozlytrek, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, the FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication. The FDA also approved a new oral pellet formulation for entrectinib, and the prescribing information now includes instructions for making an oral suspension from the capsules. In the pooled safety population of pediatric patients receiving entrectinib (n=76), the most common (≥ 20%) adverse reactions were pyrexia, constipation, increased weight, vomiting, diarrhea, nausea, cough, fatigue, pain in extremity, skeletal fracture, decreased appetite, headache, abdominal pain, urinary tract infection, upper respiratory tract infection, and nasal congestion. View full prescribing information for Rozlytrek.
- On Friday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell and consumers not to eat oysters from Future Seafoods, Inc., Prince Edward Island, Canada, from harvest area PE9B on 10/10/2023, and shipped to importers in FL, MA, MD, ME, PA, and VA, due to the possible presence of Salmonella and E. coli.
- The FDA Office of Women’s Health (OWH) works to protect, promote, and advance the health of women through research, education, and outreach. OWH, in collaboration with the Center for Drug Evaluation and Research (CDER) Office of Medical Policy (OMP), will host a free public webinar on November 8, 2023, Bringing Clinical Research to Patients. The webinar will include presentations and a panel discussion focusing on decentralized clinical trials (DCT), the CURE ID mobile app, and other novel strategies currently available for bringing clinical research to all patients, including women. DCTs are trials where some or all the trial-related activities occur at locations other than traditional clinical trial sites. DCTs may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or access to traditional trial sites. These strategies may help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse study participant population. Researchers, educators, clinicians, and patients may benefit from attending this webinar. To receive a link to attend, please register in advance.
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.
- FDA Office of Media Affairs