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About CRESEMBA®About CRESEMBA®Meet CRESEMBA®CRESEMBA® in the ICUCRESEMBA® in ActionEfficacy EfficacyInvasive AspergillosisEfficacyGuidelines MucormycosisEfficacyGuidelinesSafetySafetyTolerabilityInvasive AspergillosisMucormycosis Safety ProfileSafety ProfileDosingDosingSimple DosingLinear PKs, Low Variability and TDMPractical ConsiderationsReal-world DataReal-world DataReal-world EffectivenessReal-world SafetyResourcesResourcesSummary of Prescribing InformationEventsMaterialsVideos

Standard-of-care efficacy in mucormycosis1

CRESEMBA® achieves survival rates similar to amphotericin B in mucormycosis1

  

Liposomal amphotericin B was the only licensed antifungal agent for mucormycosis prior to the arrival of CRESEMBA®, which provided a much-needed alternative option.1,2

  

In a case-control analysis of patients with mucormycosis from the VITAL registration trial and matched case-controls from the FungiScope registry, survival was similar with CRESEMBA® and amphotericin B.1

 Survival rates in patients receiving CRESEMBA® as primary treatment in VITAL vs matched controls treated with amphotericin B (FungiScope)1,a

a. Patients were censored on the day of their last known survival status (circles).

Adapted from reference 1.

  

CRESEMBA® was associated with an overall response of 11% (complete or partial response) at Day 42 (primary endpoint), rising to 31% (complete and partial response) at the end of treatment.1

  

Weighted all-cause mortality at Day 42 was not significantly different between CRESEMBA® and amphotericin B at 33% vs 41%, respectively (p=0.595).1

  

Study design
VITAL: the registration trial for CRESEMBA® in  mucormycosis1

  


Single-arm, open-label, multicentre, international trial of CRESEMBA® in patients with rare fungal infections, including mucormycosis


Mucormycosis cases were matched with controls from the FungiScope registry who received AmB-based treatment

Primary endpoint: overall response at Day 42 as determined by an independent data review committee

b. Oral or IV loading regimen determined at the discretion of local investigators.

IV, intravenously; PO, per os (orally).

  

CI, confidence interval; HR, hazard ratio.

Prescribing Information:
CRESEMBA® (isavuconazole)

References:

Marty FM et al. Lancet Infect Dis 2016;16(7):828–837.Spellberg B et al. Clin Infect Dis 2009;48(12):1743–1751.

PP-CRB-IND-0472 July 2022

  

Mucormycosis
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