Five new medicines recommended for approval

The European Medicines Agency’s key human medicines committee (CHMP) has recommended five medicines for approval at its March 2026 meeting. This brings to 23 the total number of new products authorised in the EU this year.

The newly approved medicines are:

• 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.
• 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.
• Joenja (leniolisib) 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.
• 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.
• 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.

The committee also recommended extensions of indication for 13 medicines that are already authorised in the EU: Besponsa, Capvaxive, Feraccru, Hetronifly, Hympavzi, Imcivree, Lojuxta, Mekinist, mResvia, Namuscla, Retsevmo, Sotyktu and Tafinlar.