Kizfizo

Opinion

EMA has issued an opinion on this medicine

temozolomide

Overview

On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kizfizo, intended for the treatment of newly diagnosed glioblastoma multiforme in adults and recurrent or progressing malignant glioma in adults and children from the age of 1 year.

The applicant for this medicinal product is Orphelia Pharma.

Kizfizo will be available as a 40 mg/ml oral suspension. The active substance of Kizfizo is temozolomide, an antineoplastic alkylating agent (ATC code: L01AX03). Temozolomide undergoes rapid chemical conversion in vivo to diazomethane, responsible for alkylation and aberrant repair of DNA, leading to cytotoxic effect.

The benefits of Kizfizo in combination with radiotherapy are an improvement of overall survival in adults with newly diagnosed glioblastoma multiforme compared with radiotherapy alone; Kizfizo increased progression-free survival in paediatric and adult patients with recurrent or progressive malignant glioma compared with procarbazine. The most common side effects are nausea, vomiting, constipation, diarrhoea, anorexia, headache, fatigue, convulsions, hemiparesis, aphasia/dysphasia, alopecia and rash.

Kizfizo is a hybrid medicine

 of Temodal, which has been authorised in the EU since 26 January 1999. Kizfizo contains the same active substance as Temodal, but it is formulated as oral suspension with a different strength of 40 mg/ml and is also approved for the treatment of paediatric patients 1 to below 3 years of age.

Studies have demonstrated the satisfactory quality of Kizfizo, and its bioequivalence to the reference product Temodal.

The full indication is:

Kizfizo is indicated for the treatment of:

• adult patients with newly‑diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
• children from the age of one year, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Kizfizo should be prescribed by physicians experienced in the treatment of brain tumours.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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Notes: 

• This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

• Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

CHMP summary of positive opinion for Kizfizo

Adopted Reference Number: EMA/232747/2026

Product details

• Name of medicine:
  Kizfizo
• Active substance:
  temozolomide
• International non-proprietary name (INN) or common name:
  temozolomide
• Therapeutic area (MeSH):
  Glioma
• Anatomical therapeutic chemical (ATC) code:
  L01AX03
• EMA product number:
  EMEA/H/C/006892
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  ORPHELIA Pharma
• Opinion adopted:
  15/10/2026
• Opinion status:
  Positive