FDA Roundup: March 5, 2024

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 the availability of a final guidance for industry titled “Dietary Supplements:  New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” This guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to the FDA.
• Today, the FDA approved the first interchangeable biosimilar to Prolia (denosumab) and Xgeva (denosumab). Jubbonti (denosumab-bbdz) is an interchangeable biosimilar to U.S.-licensed Prolia for the treatment of osteoporosis in certain patient populations, and Wyost (denosumab-bbdz) is an interchangeable biosimilar to U.S.-licensed Xgeva for the treatment of bone complications from cancer. 
• On Monday, the FDA updated its list of select chemicals currently under the agency’s review to provide more insight on the status of the FDA’s post-market assessments of chemicals in the food supply. This updated list includes select food ingredients (including food and color additives), food contact substances, and contaminants under FDA review. The list also includes information about the status of our post-market assessments, including where we are in the risk assessment and management process, as well as our post-market actions. The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety.
• On Friday, the FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.  The most common adverse reactions (≥20%) were rash, nail toxicity, stomatitis, infusion-related reaction, fatigue, edema, constipation, decreased appetite, nausea, COVID-19, diarrhea, and vomiting.  The FDA also granted traditional approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The most common adverse reactions (≥ 20%) were rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. The FDA previously granted accelerated approval for this indication. View full prescribing information for Rybrevant.

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