On November 27, 2023, the U.S. Food and Drug Administration (FDA) reported that Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of crystal formation observed in some bottles that could result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of cyclosporine oral solution, USP, 100 mg/m. No other Sandimmune formulations are affected.
On November 28, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication to patients and healthcare professionals regarding BCMA- or CD19-directed autologous CAR T-cell immunotherapies. The agency said it received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with those products. The reports came from clinical trials and postmarketing adverse event data sources.
Adding hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves 10-year overall survival in patients with stage III epithelial ovarian cancer by nearly 40%, researchers reported in study findings published in Lancet Oncology.
On November 27, 2023, the U.S. Food and Drug Administration (FDA) approved nirogacestat (Ogsiveo™) for use in adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is the first approved treatment for desmoid tumors.
After an open-label, multicenter, single-arm trial demonstrated a 56% objective response rate, with 43% achieving complete responses, and an estimated 18.4-month median duration of response, the U.S. Food and Drug Administration granted glofitamab-gxbm (Columvi™) accelerated approval in June 2023.
Switching from heparin to normal saline (NS) as the preferred flushing solution for central venous catheter (CVC) lines in adult ambulatory patients with cancer saved one institution nearly $30,000 without affecting quality of care, researchers reported in the Clinical Journal of Oncology Nursing. The change also increased patient safety by reducing risk of heparin-induced thrombocytopenia or allergic reactions, the authors said.
Professional role models and mentors are vital to nurses’ personal and career development. Their influence goes beyond the classroom or workplace, extending into the very fabric of a nurse’s career and life. Celebrated in November, National Inspirational Role Models Month recognizes individuals who inspire and guide others through their actions, passion, and dedication to their work and community.
On November 21, 2023, the U.S. Food and Drug Administration (FDA) advised that Bayer issued a voluntary recall for one lot of larotrectinib (Vitrakvi®) oral solution 20 mg/ml in 100 ml glass bottles to the user level because of Penicillium brevicompactum microbial contamination observed during routine stability testing.
White patients with commercial insurance receiving care in a community setting are most likely to receive systemic anticancer therapy at the end of life, researchers reported in study findings published in the Journal of Clinical Oncology.
On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a class I recall, the most serious type of recall, where use of the product or device may result in serious injury or death.