G-BA decisions from 5 June 2025

Here are the latest G-BA decisions from the G-BA meeting held on 5 June 2025 on the early benefit assessments of Elahere, Kisqali, and Yselty.

A complete database of all previous G-BA resolutions is in my membership.

  • ​​Elahere (mirvetuximab soravtansine); 0varian cancer, fallopian tube cancer, or primary peritoneal cancer, FRα-positive, platinum-resistant, after 1 to 3 prior therapies – Orphan drug, Indication of considerable additional benefit
  • Kisqali (ribociclib); new indication: breast cancer, HR+, HER2-, early with high risk of recurrence, adjuvant therapy, combination with aromatase inhibitor – Additional benefit not proven across all 3 subgroups
  • Yselty (linzagolix); new indication: endometriosis – Additional benefit not proven
  • Amtagvi (lifileucel); melanoma – Request for RWE data collection and restriction of prescribing
  • Columvi (glofitamab); relapsed or refractory diffuse large B-cell lymphoma – Termination of request for RWE data collection and restriction of prescribing, since the conditional EMA approval was changed to full approval

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