PRAC endorsed an extension of indication for Piqray in combination with fulvestrant for postmenopausal women and men with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation following progression on endocrine-based therapy. (European Medicines Agency) - Oct 1, 2026 - Pharmacovigilance Risk
Assessment Committee (PRAC) Minutes of meeting on 6 – 9 Jul 2026: The
extension is based on Study CBYL719C2303 (C2303, EPIK-B5). Sections 4.2, 4.4,
4.8, 5.1 and 5.2 of the SmPC were updated accordingly. [AI generated summary]
PRAC • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology
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