Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its May 2025 meeting. The committee recommended granting a conditional marketing authorisation for Aucatzyl* (obecabtagene autoleucel), for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukaemia, a type of cancer of the white blood cells. This medicine was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below. A positive opinion was adopted for Blenrep* (belantamab mafodotin), for the treatment of relapsed or refractory multiple myeloma, a rare and incurable disease of the plasma cells, which typically affects adults from 60 years of age. The committee recommended granting a conditional marketing authorisation for Ezmekly* (mirdametinib), for the treatment of paediatric and adult patients with neurofibromatosis type 1, an inherited disease in which the patient develops benign (non-cancerous) tumours along the nerves. Itovebi (inavolisib) received a positive opinion from the CHMP for the treatment of adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative locally advanced and metastatic breast cancer. The CHMP adopted a positive opinion under exceptional circumstances for Maapliv* (amino acids), for the treatment of maple syrup urine...