Summary

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• Fetroja (cefiderocol) is indicated in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms, and for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
• This summary is based on the review of seven systematic review(s)/meta-analysis(es). ^[1-7]
• Cefiderocol demonstrated a 30-day mortality rate of 42% in patients treated for carbapenem-resistant Acinetobacter baumannii (CRAB) infections, significantly lower than the best available therapy (RR: 0.74; 95% CI: 0.57-0.95, p=0.02).
• The microbiological and clinical failure rates for cefiderocol were 48% and 43%, respectively, with no significant differences compared to the best available therapy.
• In off-label use, cefiderocol was effective against multi/extensively drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii, particularly in bacteremia/sepsis cases.
• The rate of adverse drug reactions (ADRs) for cefiderocol was 3%, significantly lower compared to best available therapy (BAT) (RR: 0.28; 95% CI: 0.09-0.91, p=0.03).
• Cefiderocol was generally well-tolerated, with a safety profile similar to comparator drugs in randomized controlled trials (RCTs), and side effects were uncommon and rarely use-limiting in off-label use.
• There is no population types or subgroups information available in the reviewed studies.