Europe's drug regulator just greenlit a new liquid form of a brain cancer staple. The EMA's CHMP has recommended Kizfizo, a temozolomide oral suspension, for adults with newly diagnosed glioblastoma and for patients aged 1 and older with recurrent or progressive malignant glioma. The formulation extends access to young children previously excluded from treatment with the capsule form.
Europe's drug regulator just greenlit a new liquid form of a brain cancer staple. The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Kizfizo — a 40 mg/mL oral suspension of temozolomide — for adults with newly diagnosed glioblastoma (alongside radiotherapy, then as monotherapy) and for patients aged 1 year and older with recurrent or progressive malignant glioma. It's a hybrid of Temodal, the capsule formulation that's been EU-authorized since 1999, but crucially extends eligibility to children as young as 1 year old.
The recommendation is backed by a pivotal phase 3 trial and bioequivalence data confirming the suspension performs comparably to the capsule. The European Commission will now decide on formal marketing authorization, and the EMA will assess whether Kizfizo's orphan medicinal product designation — granted in August 2025 — can be maintained.
By the Numbers
Why it matters: Kizfizo fills a real gap — the liquid formulation makes dosing feasible for young children and patients who can't swallow capsules, broadening access to a proven brain tumor therapy.
