Isavuconazol (3) – Cresemba®

• Clinical trials
  • Study 9766-CL-0107 is a single-arm, open-label, multicentre Phase II study investigating the safety, pharmacokinetics and efficacy of isavuconazole in children and adolescents aged 1 to ≤ 17 years with invasive aspergillosis or mucormycosis.

Children and adolescents aged 1 to ≤ 17 years with mucormycosis for whom treatment with amphotericin B is not appropriate

• For children and adolescents aged 1 to ≤ 17 years with mucormycosis for whom treatment with amphotericin B is not appropriate, there is a hint of a non-quantifiable additional benefit, as the scientific data do not permit quantification.
• The strength of the evidence is classified as ‘hint’.
• For the present benefit assessment, the patient population of individuals with mucormycosis is particularly relevant.
• Only one patient with confirmed or probable mucormycosis was included in the study. However, this patient does not correspond to the therapeutic indication under assessment, as treatment with amphotericin B was used as follow-up therapy to the study medication.
• There are therefore no data available on the efficacy of isavuconazole in children and adolescents aged one year and over with mucormycosis for whom treatment with amphotericin B is not appropriate.
• Overall review
  • For the present benefit assessment of the treatment of mucormycosis in children and adolescents aged 1 to ≤ 17 years, the results of the pivotal, single-arm, open-label, multicentre Phase II study 9766-CL-0107 investigating the safety, pharmacokinetics and efficacy of isavuconazole in children and adolescents aged 1 to ≤ 17 years with invasive aspergillosis or mucormycosis.
  • Overall, the G-BA classifies the extent of the additional benefit as non-quantifiable, as the scientific evidence does not permit quantification.

Courtesy translation only, please refer to the German original.