CHMP adopted a positive opinion by consensus for the update of sections 4.8 and 5.1 of the SmPC for Opdualag based on updated descriptive 4-year data from pivotal study CA224047. (European Medicines Agency) - Oct 12, 2026 - CHMP Final Minutes of the
meeting on 20 - 23 Apr 2026: Although the EMA did not recommend
extending the indication to patients with advanced melanoma whose tumours
express PD-L1 at levels of 1% or higher, relevant data on treatment effects in
patients with PD-L1 expression below 1% were agreed for inclusion in the
product information. The Package Leaflet was updated accordingly, and the CHMP
Assessment Report and translation timetable were adopted.
CHMP • Melanoma • Oncology
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