CHMP’s March 2026 meeting delivered a broad set of EU regulatory updates.
New medicines recommended for approval (5)
- Adstiladrin (nadofaragene firadenovec): conditional marketing authorisation for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (± papillary tumours).
- Imdylltra (tarlatamab): marketing authorisation for relapsed extensive-stage small cell lung cancer; described as addressing an unmet medical need.
- Joenja (leniolisib): authorisation under exceptional circumstances for APDS in patients ≥12 years and ≥45 kg; incidence estimated at 1–2 per million.
- Zepzelca (lurbinectedin): maintenance in extensive-stage small cell lung cancer after non-progression following first-line induction.
- Bopediat (furosemide): paediatric-use marketing authorisation (PUMA); hybrid application.
Other CHMP outcomes
- 13 medicines received positive opinions for extensions of indication.
- Hetlioz re-examination: CHMP confirmed refusal of an extension for Smith-Magenis syndrome sleep disturbance.
- Tecovirimat SIGA: CHMP recommended it should no longer be used for mpox.
- CHMP adopted a reflection paper on a tailored clinical approach in biosimilar development.
Read more at https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2026
