CHMP adopted a request for supplementary information with a specific timetable regarding the proposed extension of indication for Piqray in combination with fulvestrant for postmenopausal women and men with HR +ve, HER2 -ve, PIK3CA-mutated locally advanced or metastatic breast cancer, based on study CBYL719C2303 (EPIK-B5). (European Medicines Agency) - Oct 12, 2026 - CHMP Final Minutes of the
meeting on 20 - 23 Apr 2026: The proposed variation includes updates to
sections 4.2, 4.4, 4.8, 5.1, and 5.2 of the SmPC, along with corresponding
revisions to the Package Leaflet. RMP version 10.0 was also submitted.
CHMP • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology
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