Piqray (alpelisib) is the only treatment approved specifically to address PIK3CA mutation
The approval was based on SOLAR-1 Phase III trial showing Piqray plus fulvestrant nearly doubled median PFS (11.0 vs. 5.7 months) in HR+/HER2- advanced breast cancer patients with PIK3CA mutation, compared to fulvestrant alone.
Approximately 30-40% of those with HR+/HER2- subtype have a PIK3CA mutation, which is associated with a poor prognosis. In Singapore, the incidence of point mutations in PIK3CA, are amongst the most frequently reported to date for any gene in breast cancer.
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