Introduction
European Medicines Agency (EMA) published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) held from 23 to 26 March 2026. The meeting covered recommendations on new medicines, extensions of indications, and outcomes of regulatory procedures.
Recommendations for New Medicines
The CHMP recommended several medicines for marketing authorisation.
These include:
- Adstiladrin (nadofaragene firadenovec), recommended for conditional marketing authorisation for the treatment of bladder cancer unresponsive to (Bacillus Calmette-Guérin) BCG.
- Imdylltra (tarlatamab), recommended for the treatment of relapsed extensive-stage small cell lung cancer.
- Joenja (leniolisib), recommended under exceptional circumstances for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS), a rare disease.
- Zepzelca (lurbinectedin), recommended as a maintenance treatment in patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy.
- Bopediat (furosemide), recommended as a hybrid application with a paediatric-use marketing authorisation.
Extensions of Indications
The CHMP recommended extensions of indications for several medicines already authorised in the European Union.
A total of 13 extension applications received positive recommendations during this meeting.
These include Besponsa, Capvaxive, Feraccru, Hetronifly (with two indication extensions), Hympavzi, Imcivree, Lojuxta, Mekinist (with two indication extensions), mResvia, Namuscla, Retsevmo, Sotyktu, and Tafinlar (with two indication extensions).
Re-examination Outcome
Following a re-examination procedure, the CHMP confirmed its previous recommendation to refuse the extension of indication for Hetlioz (tasimelteon).
Withdrawal of Application
The application for marketing authorisation for Blarcamesine Anavex (blarcamesine), intended for the treatment of Alzheimer’s disease, was withdrawn during the evaluation process.
Referral Procedure
The CHMP finalized a referral procedure for Tecovirimat SIGA (tecovirimat), an antiviral medicine authorised for the treatment of smallpox, mpox, and cowpox—three infections caused by viruses from the same family, known as orthopoxviruses.
The Committee concluded that this medicine should not be used for the treatment of mpox.
Other updates
The committee approved a new route of administration—subcutaneous—along with a new pharmaceutical form and strength for Sarclisa, a cancer treatment for adults with multiple myeloma.
In addition, the committee adopted a reflection paper outlining a tailored clinical approach to biosimilar development. This approach is intended to reduce the amount of clinical data required for the development and approval of certain biosimilar medicines in the EU. Biosimilars are biological medicines that are highly similar to an already authorised reference product and are approved under the same standards of quality, safety, and efficacy as all biological medicines.
Conclusion
The CHMP meeting included decisions related to new marketing authorisations, extensions of indications, re-examination outcomes, withdrawals, and referral procedures.
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For more information: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026
