Novartis Korea said Friday that the Ministry of Food and Drug Safety has approved Piqray (ingredient: alpelisib) for treating menopausal patients with advanced breast cancer through combined use with fulvestrant....The drug can be prescribed to menopausal women with breast cancer whose tumors have PIK3A mutation and are hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 (HER2) negative...

We reviewed charts of patients diagnosed with metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 negative, PIK3CA-mutated breast cancer treated with alpelisib....Clinical responses were determined using RECIST v1.1. 3/27 (11.11%) patients discontinued therapy before response assessment due to grade 3 AEs. Overall response rate was 12.5% (3/24), with all partial responses (PR). The median duration of response was 5.77 months (range: 5.54, 8.98). 14/27 (51.9%) of patients required dose interruption/reduction.

...52 patients with HR-positive, PIK3CA-mutated ABC that had progressed after antiestrogen therapy were treated with alpelisib plus fulvestrant. Of these, 7 patients (13.5%) reached long-term disease control and 5 patients (9.6%) achieved very long-term disease control.