CHMP Updates - December'25

Highlights from the CHMP Dec 2025 Meeting are out!

New Medicines

💊 Conditional marketing authorisation of ImmunityBio, Inc.'s nogapendekin alfa inbakicept (Anktiva: IL-15 superagonist complex) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours

💊 Jiangsu Hansoh Pharmaceutical Group Co., Ltd.’s aumolertinib (Aumseqa: EGFR-TKI) as monotherapy is indicated for the first‑line treatment of adult patients with advanced non‑small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and for the treatment of adult patients with advanced EGFR T790M mutation‑positive NSCLC

👉 Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at support@oncofocus.com, and we will take it from there.

🌐 Reference: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-december-2025