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CHMP Updates - September'26
Highlights from the CHMP September 2026 Meeting are out! π’ 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. π The CHMP dropped the cisplatin-ineligibility restriction for Keytruda + Padcev in resectable muscle-invasive bladder cancer 2) The label race has moved upstream. π All five oncology extensions took a therapy into an earlier setting or a wid

Oncofocus Team
Sep 211 min read
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CHMP Updates - July'26
Highlights from the CHMP July 2026 Meeting are out! Six oncology calls came out of the July CHMP meeting. Below are the key takeaways: 1) ADCs own the front line. π Enhertu and Trodelvy both cleared first-line metastatic breast settings in combination. 2) Breast cancer is where the density is. π All three positive opinions are in the Breast Cancer space 3) A met endpoint is not an EU approval. π POTOMAC succeeded, and the FDA approved. CHMP still questioned the benefit-ris

Oncofocus Team
Aug 131 min read
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