CHMP October 2026 meeting: approvals, indication changes and withdrawals
- CHMP recommended marketing authorisation for Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma after at least one prior treatment.
- Recommended Foundayo (orforglipron), an oral once‑daily GLP‑1 receptor agonist, for weight management and treatment of type 2 diabetes in adults.
- Positive opinions adopted for biosimilars Fovlussea (ranibizumab) and Neuzafy (filgrastim); Kizfizo (temozolomide) recommended for adults with glioblastoma multiforme and children with malignant glioma via a hybrid application.
- Re‑examination confirmed refusal for Yartemlea (narsoplimab); companies withdrew extension applications for Ibrance and Truqap; Nyxoid (naloxone) recommended to become available without prescription.
Six new medicines
The CHMP issued positive opinions for six medicines: Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma after at least one prior treatment following a phased review and Cancer Medicines Pathfinder prioritisation; Foundayo (orforglipron), an oral once‑daily GLP‑1 receptor agonist for weight management and type 2 diabetes in adults; Yuviwel (navepegritide) for achondroplasia in children; biosimilars Fovlussea (ranibizumab) for multiple retinal conditions and Neuzafy (filgrastim) for neutropenia; and Kizfizo (temozolomide) for adults with glioblastoma multiforme and children with malignant glioma, filed as a hybrid application.
Extensions of indication
The committee recommended extensions of therapeutic indication for five authorised medicines: Pandemic influenza vaccine H5N1 AstraZeneca, Kyinsu, Talvey, Tryngolza and Tukysa.
Re‑examination and withdrawals
After re‑examination the CHMP confirmed its recommendation to refuse marketing authorisation for Yartemlea (narsoplimab) for HSCT‑associated thrombotic microangiopathy. Companies withdrew applications to extend Ibrance (palbociclib) to maintenance treatment for HR‑positive, HER2‑positive advanced/metastatic breast cancer and Truqap (capivasertib) for metastatic prostate cancer with PTEN loss. Question‑and‑answer documents on these outcomes are available.
Other updates and administration
The CHMP finalised but did not recommend an extension for Mylotarg (gemtuzumab ozogamicin) to children aged 1 to under 18 with newly diagnosed AML, agreeing instead to include study data in the product information. It recommended changing Nyxoid (naloxone) to non‑prescription status. The meeting agenda is published on EMA’s website and minutes will follow.
Source: EMA