CHMP Updates - February'26

Highlights from the CHMP Feb 2026 Meeting are out!

New Medicines

💊 Ipsen's tovorafenib (Ojemda; Type II RAF kinase inhibitor) is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low‑grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies

New Biosimilars

💊 Henlius and Organon's pertuzumab (Poherdy; HER2/neu receptor antagonist), an interchangeable biosimilar biological product to pertuzumab (Perjeta) is intended for the treatment of breast cancer

Indication Expansions

💊 Merck & Co/MSD's pembrolizumab (Keytruda; anti-PD-1 mAb) in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD‑L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens

💊 Novartis' asciminib (Scemblix; STAMP inhibitor) is indicated for the treatment of adult patients with Ph+ chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib

👉 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-23-26-february-2026