CHMP Updates - September'26
Highlights from the CHMP September 2026 Meeting are out!
📢 At the Sep'26 CHMP meeting, nine positive opinions related to oncology were reported. Here are the main highlights:
1) Cisplatin is no longer the gatekeeper in bladder cancer.
👉 The CHMP dropped the cisplatin-ineligibility restriction for Keytruda + Padcev in resectable muscle-invasive bladder cancer
2) The label race has moved upstream.
👉 All five oncology extensions took a therapy into an earlier setting or a wider population. Enhertu moves into adjuvant setting in early breast cancer
3) Biosimilar evidence standards are changing.
👉 Biocon Biologics' Pebrilzo (pertuzumab) is the first biosimilar the CHMP has recommended under EMA's tailored clinical approach. Under that approach, a biosimilar can skip comparative efficacy studies when analytical and pharmacokinetic data are sufficient.
đź“Ž Refer to this link to check with the ppt - https://www.linkedin.com/posts/oncofocus-solutions_chmp-updatesseptember-2026-activity-7506764292768034816-HGef?utm_source=share&utm_medium=member_desktop&rcm=ACoAAD8_WBgBZZOtB9V3KVxAPgArz0lfddfRhLw
📧 To access the full presentation or to discuss these findings in more detail, please contact us at support@oncofocus.com.
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