Kizfizo (temozolomide)

Where it stands

Kizfizo (temozolomide), from ORPHELIA Pharma, received a positive CHMP opinion on 2026-10-15. The records show no approval date, so the product is at the opinion stage and does not yet have EU marketing authorisation.

The proposed indication is the treatment of adults with glioblastoma multiforme and children with malignant glioma. The therapeutic area is recorded as glioma.

A positive CHMP opinion is a scientific recommendation. It becomes legally effective only when the European Commission adopts a decision, and the product cannot be marketed in the EU before then.

Regulatory pathway and designations

The product carries an orphan designation, and the CHMP opinion is recorded as positive for ORPHELIA Pharma. The records do not say whether orphan status will be maintained at the time of authorisation, or what benefit or market exclusivity might follow. In general, that is assessed separately from the CHMP opinion, so it should not be assumed.

The expected EC decision is 2026-12-21. This is an estimate, not an official date. It is calculated as the CHMP opinion date plus 67 days, the standard Commission decision period. The actual date could differ.

The records list other EU products with the same substance: Temodal, Temozolomide Sun, Temozolomide Accord and Temozolomide Teva are authorised, and Temozolomide Sandoz is withdrawn. They also list an earlier EU entry named Kizfizo with status Refused. The records give no detail on how that entry relates to the current opinion, such as the applicant, the procedure or the reasons for refusal. Readers should check the EMA public documentation before drawing conclusions.

Safety and pharmacovigilance

The records contain no safety, risk management or pharmacovigilance information for Kizfizo, so this analysis cannot comment on them.

What to watch

The first item is the European Commission decision, estimated for around 2026-12-21. Confirm the actual outcome and date against official sources, because the estimate is not binding.

The second is how the earlier Refused Kizfizo entry relates to this opinion, and what the public assessment documents say about it. The records do not explain the connection.

The third is whether orphan status is maintained at authorisation. The product will also enter a market where several temozolomide products are already authorised, and the records give no information on how Kizfizo is differentiated from them.