CHMP adopted a positive opinion by consensus recommending the extension of indication for Piqray in combination with fulvestrant, for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer, based on study CBYL719C2303 (EPIK-B5). (European Medicines Agency) - Oct 17, 2026 - CHMP Final Minutes of the
meeting on 20 - 23 Jul 2026: The Committee confirmed that all previously
identified issues had been addressed. Sections 4.2, 4.4, 4.8, 5.1, and 5.2 of
the SmPC are updated, with corresponding revisions to the Package Leaflet. The
CHMP Assessment Report and translation timetable were also adopted.
CHMP • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology
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