Five novel medicines backed for approval by EMA/CHMP
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its December 2025 meeting.
The committee recommended granting a conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept), from Serum Life Science Europe, for the treatment of adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and that is at high risk of growing and spreading. Bladder cancer is one of the most common cancers in the European Union (EU), affecting over 200,000 people each year, with most cases being NMIBC.
The CHMP recommended granting a marketing authorization for SFL Pharmaceuticals Deutschland’s Aumseqa (aumolertinib), for the treatment of EGFR-mutated non-small cell lung cancer.
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