News / 18 October 2026
CHMP recommends six new medicines at its October 2026 meeting
The European Medicines Agency's human medicines committee (CHMP) recommended six medicines for approval at its October 2026 meeting.[1] It also recommended extensions of indication for five medicines already authorised in the European Union.[1]
Rasonque (daraxonrasib) received a positive opinion for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment.[1] The recommendation follows a phased review, and Rasonque was identified as a high-priority medicine under EMA's Cancer Medicines Pathfinder project.[1]
The committee also recommended a marketing authorisation for Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and treatment of type 2 diabetes in adults.[1] It is a tablet taken once daily.[1] Yuviwel (navepegritide) was recommended for the treatment of achondroplasia in children.[1]
The committee adopted positive opinions for two biosimilar medicines.[1] One is Fovlussea (ranibizumab), for neovascular (wet) age-related macular degeneration and other visual impairments.[1] The other is Neuzafy (filgrastim), for the treatment of neutropenia in adults and children.[1] Kizfizo (temozolomide) was recommended for adults with glioblastoma multiforme and children with malignant glioma.[1] Kizfizo was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product, and in part on new data.[1]
The committee recommended changing the legal status of Nyxoid (naloxone) so that it is available without a medical prescription.[1] Applications to extend the use of two medicines were withdrawn.[1] One concerned Ibrance (palbociclib), for maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer.[1] The other concerned Truqap (capivasertib), for metastatic prostate cancer that responds to hormone treatment when the cancer cells lack a protein called PTEN.[1] The CHMP did not recommend extending the use of Mylotarg (gemtuzumab ozogamicin) to children aged one to less than 18 years with newly diagnosed acute myeloid leukaemia.[1]
Background
The October figures show 0 negative opinions on new medicines, with a total of 8 in 2026.[1] There were 5 positive opinions on extensions of therapeutic indication in October, and the 2026 total is 97.[1]
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Sources
- European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2026. Published 2026-10-16. Read the source
Checked 18 October 2026. How we check sources