Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026
Five new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2026 meeting.
The committee recommended granting a conditional marketing authorisation for Adstiladrin (nadofaragene firadenovec), for the treatment of adult patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours.
The CHMP recommended granting a marketing authorisation for Imdylltra (tarlatamab), a new treatment for relapsed extensive-stage small cell lung cancer which addresses an unmet medical need in adults with poor prognosis and limited treatment options. See more details in the news announcement in the grid below.
Joenja (leniolisib) received a positive opinion for a marketing authorisation under exceptional circumstances for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more. APDS is a rare, inherited progressive and potentially life-threatening condition of the immune system. The incidence rate of this disease around the world is estimated to be 1 to 2 per million people.
A positive opinion was adopted for Zepzelca (lurbinectedin) for the maintenance treatment in patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy.
The CHMP recommended granting a paediatric-use marketing authorisation (PUMA) for Bopediat (furosemide) for the treatment of oedema (swelling caused by excess fluid) of cardiac or renal origin, oedema of hepatic origin and hypertension in children from birth to under 18 years of age with chronic kidney disease. This medicine was submitted in a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product and in part on new data.
Recommendations on extensions of therapeutic indication for 13 medicines
The committee recommended extensions of indication for 13 medicines that are already authorised in the EU: Besponsa, Capvaxive, Feraccru, Hetronifly (two extensions of therapeutic indication), Hympavzi, Imcivree, Lojuxta, Mekinist (two extensions of therapeutic indication), mResvia, Namuscla, Retsevmo, Sotyktu and Tafinlar (two extensions of therapeutic indication).
Outcome of re-examination
After re-examining its initial opinion, the committee confirmed its recommendation to refuse a change to the marketing authorisation for Hetlioz (tasimelteon). The change concerned an extension of indication to include the treatment of nighttime sleep disturbance in adults and children aged 3 to 15 years with Smith-Magenis syndrome, a rare hereditary disorder characterised by developmental delay, behavioural problems and sleep disturbance.
The CHMP issued this opinion during an extraordinary meeting on 16 March 2026.
Withdrawal of application
An application for an initial marketing authorisation was withdrawn. Blarcamesine Anavex (blarcamesine) was developed for the treatment of Alzheimer’s disease and dementia.
A question-and-answer document on the withdrawal of this application is available in the grid below.
Conclusion of referral
The committee finalised its review of Tecovirimat SIGA (tecovirimat), an antiviral medicine that was authorised to treat smallpox, mpox and cowpox, three infections caused by viruses belonging to the same family (orthopoxviruses). The CHMP recommended that Tecovirimat SIGA should no longer be used for the treatment of mpox. The review of Tecovirimat SIGA was initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
For more information, see the public health communication in the grid below.
Other updates
The committee adopted a new route of administration, subcutaneous, together with a new pharmaceutical form and a new strength for Sarclisa, a cancer medicine used to treat adults with multiple myeloma.
The committee adopted a reflection paper on a tailored clinical approach in biosimilar development, which aims to reduce the amount of clinical data required for the development and approval of certain biosimilar medicines in the EU. A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
Agenda and minutes
The agenda of the March 2026 CHMP meeting is published on EMA’s website. Minutes of the meeting will be published in the coming weeks.
