The Priority Review

Tag

temozolomide

1 story

  1. Approvals

    CHMP recommends marketing authorisation for Kizfizo

    The Committee for Medicinal Products for Human Use adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Kizfizo, a 40 mg/ml oral suspension of temozolomide, for newly diagnosed glioblastoma multiforme in adults and for recurrent or progressing malignant glioma in adults and children from the age of one year. The applicant is Orphelia Pharma and the product is designated an orphan medicine.