May batch of novel medicines recommended for approval by CHMP

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended six novel medicines for approval at its May 2025 meeting. Final approvals from the European Commission are now expected in the third quarter of this year.

The committee recommended granting a conditional marketing authorization for Autolus GmbH’s Aucatzyl (obecabtagene autoleucel), for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia, 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.

A positive opinion was adopted for UK Pharma major GSK’s (LSE: GSK) 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. This recommendation should clear the path for Blenrep's market return.