August 15, 2023 - FDA Roundup: August 15, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA announced a request for information on a citizen petition asking the FDA to amend the standard of identity for pasteurized orange juice by lowering the minimum soluble solids content, known as the Brix level.  Comments are due by October 16, 2023.  
• On Monday, the FDA’s National Center for Toxicological Research (NCTR), published a Research Highlight about a renowned scientist in NCTR’s Division of Biochemical Toxicology, Dr. Igor Pogribny, who was inducted into the Arkansas Research Alliance (ARA) Academy of Scholars and Fellows. Dr. Pogribny was selected for being a recognized research leader in the field of molecular toxicology and carcinogenesis with an established history of impact.
• On Monday, the FDA approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. The prescribing information for the HEPZATO KIT has a Boxed Warning for severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events. The prescribing information also has a Boxed Warning for myelosuppression with resulting severe infection, bleeding, or symptomatic anemia. Because of the risk of severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events, HEPZATO KIT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS. View full prescribing information for the HEPZATO KIT.
• On Monday, the FDA published “Catching Up with Califf: FDA’s Dietary Supplements Program Remains a Critical Priority,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. The FDA is embarking on an ambitious plan to transform the current organizational structure in the various foods programs into a unified Human Foods Program. These changes will improve how the agency protects the nation’s food supply, improve access to safe and nutritious foods and enhance the understanding of chemical safety and nutrition. This blog shares more details about the FDA’s dietary supplements program under the proposed reorganization.
• On Monday, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The prescribing information for elranatamab-bcmm has a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Among patients who received elranatamab-bcmm at the recommended dose, CRS occurred in 58% of patients, neurologic toxicity in 59%, and ICANS in 3.3%. Grade 3 CRS occurred in 0.5% of patients and Grade 3 or 4 neurologic toxicity occurred in 7%. Because of the risks of CRS and neurologic toxicity, including ICANS, elranatamab-bcmm is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), called the ELREXFIO REMS. View full prescribing information for Elrexfio.
• On Friday, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. The most common adverse reactions (≥20%), including laboratory abnormalities, were decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, and increased AST. View full prescribing information for Akeega.
• On Friday, the FDA warned consumers and patients to not use the following tests manufactured by Universal Meditech Inc. (UMI):
  • One Step Pregnancy Test 
  • DiagnosUS One Step Ovulation Test 
  • HealthyWiser UriTest 10 Parameter Reagent Test Strips for Urinalysis 
  • HealthyWiser UriTest UTI Test Strips 
  • HealthyWiser KetoFast Ketone Test Strips 
  • HealthyWiser pH-Aware pH Test Strips 
  • To Life hCG Pregnancy Urine Test 
  • Am I Pregnant Pregnancy Midstream Test 
  • DeTec hCG Pregnancy Urine Test 
  • PrestiBio Pregnancy Strips
  • PrestiBio Rapid Detection Pregnancy Test Midstream
  • PrestiBio Ovulation Strips
  • PrestiBio Urinalysis Test Strip 10 Parameters
  • PrestiBio Ketone Test Strips
  • PrestiBio Breast Milk Alcohol Test Strips
  UMI has notified the FDA that it has stopped all operations and is no longer providing support for its tests. The FDA is unable to confirm the performance of these tests, raising concerns that the tests may not be safe and effective. For more information, please visit the FDA safety communication here.

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