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EMA recommends five new medicines addressing rare diseases and aggressive cancers

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The European Medicines Agency (EMA) has recommended five new medicines for approval following its Committee for Medicinal Products for Human Use (CHMP) meeting in March 2026, marking another step forward in addressing unmet medical needs across oncology, rare diseases and paediatrics.

Among the highlights is Adstiladrin (nadofaragene firadenovec), recommended for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer. The committee also recommended Imdylltra (tarlatamab) for approval, a novel treatment for relapsed extensive-stage small cell lung cancer (SCLC), a disease with particularly poor prognosis and limited treatment options.

Commenting on Imdylltra, Amgen said: “SCLC is one of the most aggressive solid tumors, accounting for approximately 13-15% of lung cancer diagnoses worldwide. While patients may initially respond to chemotherapy, most relapse within months and long-term survival... 

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