EMA Declines Pediatric Extension for AML Drug Edited by Joyani Das (+++)

https://www.medscape.com/viewarticle/ema-declines-pediatric-extension-aml-drug-2026a10013lb?src= Children with newly diagnosed acute myeloid leukemia (AML) in Europe will not gain a new targeted option for now. The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has finalized its assessment of an application to extend the use of Mylotarg (gemtuzumab ozogamicin, Pfizer) to children aged 1 year to less than 18 years with newly diagnosed AML, in combination with cytarabine and mitoxantrone. The committee did not recommend the new use. EMA Upholds Rejection of Posttransplant Complication Drug Edited by Joyani Das https://www.medscape.com/viewarticle/ema-upholds-rejection-posttransplant-complication-drug-2026a10013l6?src= The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed its recommendation to refuse marketing authorization for narsoplimab (Yartemlea, Omeros Ireland Limited) for hematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy (TA-TMA). The opinion, adopted on October 15, 2026, follows a re-examination requested by the company after the committee’s initial negative opinion on June 25, 2026. EMA Backs Oral Suspension for Malignant Brain Tumors https://www.medscape.com/viewarticle/ema-backs-oral-suspension-malignant-brain-tumors-2026a10013l2?src= At its October 2026 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended Kizfizo (temozolomide, Orphelia Pharma) 40 mg/mL oral suspension for adults with newly diagnosed glioblastoma and for adults and children aged 1 year or older with recurrent or progressive malignant glioma. Kizfizo is a hybrid medicine of Temodal, the capsule formulation authorized in the EU since January 26, 1999. It contains the same active substance. The new product differs in being a 40 mg/mL suspension, and it extends approval to patients aged 1 year to less than 3 years.