October 24, 2023

On October 24, 2023, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) variant, as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic device to select patients for ivosidenib treatment.

October 24, 2023

After a single-arm clinical trial demonstrated an overall response rate of 31.7% in 106 patients with folate receptor (FR) alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, the U.S. Food and Drug Administration granted mirvetuximab soravtansine-gynx (Elahere®) accelerated approval on November 14, 2022.  

October 20, 2023

On October 20, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek®) 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 variant, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.

October 20, 2023

Burnout knows no borders. The nursing workforce crisis cares little about country lines or continents. Regardless of their time zone, nurses in all settings are leaving the profession. “Healthcare systems are ailing, and they are in urgent need of healing. [We] call to action health system executives and other leaders to support, promote, and enable bold experiments to avert additional personnel losses and improve patient outcomes,” ONS member Christopher Friese, PhD, RN, AOCN®, and colleagues wrote in a July 2023 NAM Perspectives commentary.

October 19, 2023

“The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids. We are committed to a multipronged approach using regulation, compliance, and enforcement action and education to protect our nation’s youth.” 

—Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner 

October 17, 2023

Approximately 10% of cancers are linked to a germline (inherited) pathogenic variant, which can be confirmed with germline susceptibility testing of a blood, skin, or saliva sample (not a tumor specimen). Identification of individuals with a germline pathogenic variant helps clinicians predict their risk for developing malignancies and provide recommendations for cancer prevention and early detection. If an individual develops a tumor, subsequent somatic predictive or prognostic biomarker tumor testing may be indicated.