Merck & Co., Inc. announced that the US Food and Drug Administration (FDA) has approved an expanded label for Cancidas, which makes it the first and only echinocandin therapy approved in the United States for the treatment of paediatric patients aged 3 months to 17 years with indicated fungal infections.
In the United States, Cancidas is now indicated in adults and paediatric patients (3 months and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. Cancidas has not been studied in endocarditis, osteomyelitis and meningitis due to Candida; Treatment of Esophageal Candidiasis; Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). Cancidas has not been studied as initial therapy for invasive aspergillosis.
Cancidas is a member of the echinocandin class of antifungals. Cancidas inhibits the synthesis of -D-glucan, an integral component of the fungal cell wall. Cancidas should be administered via slow intravenous infusion over approximately one hour. Cancidas should not be administered by I V bolus administration.
The efficacy and safety of Cancidas has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age.
"In the paediatric population, safety and tolerability can be especially critical. With the expanded label for Cancidas that now includes use in paediatric patients aged 3 months to 17 years, clinicians have a new option - with both a demonstrated efficacy and safety profile - for treating these paediatric patients with indicated fungal infections," said Dr. Theoklis Zaoutis, assistant professor, Paediatrics and Epidemiology, Division of Infectious Diseases, Children's Hospital, Philadelphia, and lead study investigator.
The expanded label for Cancidas is based on data from five prospective clinical studies involving 171 paediatric patients. Two clinical trials demonstrated the efficacy of Cancidas for the treatment of paediatric patients with indicated fungal infections, and demonstrated a safety and tolerability profile comparable to that of adults. The expanded label also includes consistent dosing for paediatric patients across all indications based on multiple pharmacokinetic studies.
As part of the expanded label, precise dosing of Cancidas in paediatric patients aged 3 months to 17 years should be based on the patient's body surface area (BSA). For all indications, a single 70-mg/m² loading dose (not to exceed an actual dose of 70 mg) should be administered on Day One, followed by 50 mg/m² daily thereafter (not to exceed an actual dose of 70 mg daily). CANCIDAS is the only antifungal with well-studied BSA dosing in paediatric patients.
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