Article
What We're Reading: FDA Addressing Baby Formula Imports; Nivolumab, Ipilimumab in Urothelial Carcinoma; Antibiotics Linked With IBD
Author(s):
FDA to make an announcement regarding importation of baby formula; first-line use of nivolumab and ipilimumab vs standard of care chemotherapy fails to meet primary end point of overall survival in phase 3 CheckMate 901 trial; study finds link between antibiotic prescriptions and inflammatory bowel disease diagnosis in older adults.
FDA to Address Baby Formula Imports
Reuters is reporting that the FDA will make an announcement as soon as later today regarding potential policy changes on the importation of baby formula. FDA Commissioner Robert Califf, MD, noted in an interview that he does not expect the shortage of baby formula to last until the end of the year, as manufacturer Abbott Laboratories, whose facility in Sturgis, Michigan, was closed amid investigations that concluded it failed to maintain sanitary conditions, is likely to reopen that facility in about 2 weeks. The United States currently does not import baby formula from abroad.
Nivolumab, Ipilimumab Combo Fails First-line Study in Urothelial Carcinoma
Bristol Myers Squibb announced today that its phase 3 CheckMate 901 trial investigating the use of nivolumab (Opdivo) plus ipilimumab (Yervoy) vs standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma did not meet the primary end point of overall survival in patients whose tumor cells express programmed death-ligand 1 (PD-L1) greater than or equal to 1 at final analysis. An independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary end points, with current studies underway investigating the combination therapy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy.
Antibiotics Linked With IBD in Older Adults, Study Finds
A study selected for presentation at Digestive Disease Week 2022 found that antibiotic use in people 60 years and older was associated with a 64% increase in their risk of developing ulcerative colitis and Crohn disease—the main subtypes of inflammatory bowel disease (IBD). CIDRAP is reporting that risk rose with each additional dose of antibiotics among participants, and risk of IBD was highest among those who had been prescribed antibiotics 1 to 2 years prior to diagnosis vs patients who had received antibiotics 2 to 5 years before diagnosis.
