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At Novartis, our mission is to discover new ways to improve and extend people's lives. We use science-based innovation to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
KISQALI® (ribociclib) is a prescription medicine used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has gotten worse or has spread to other parts of the body (metastatic), in combination with: 1. An aromatase inhibitor as the first endocrine-based therapy regardless of premenopausal status 2. Fulvestrant as the first endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women
Piqray (alpelisib) is a kinase inhibitor approved in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an MFDS-approved test following progression on or after endocrine-based regimen. Approximately 40% of HR+ advanced breast cancer patients have a mutation that may activate the PI3K-alpha isoform, called PIK3CA mutations. These mutations are associated with resistance to endocrine therapy, disease progression and a poor prognosis. Piqray works by inhibiting the PI3K pathway, predominantly the PI3K-alpha isoform, to address the effect of PIK3CA mutations. SOLAR-1 (NCT02437318) was a randomized, double-blind, placebo-controlled trial of PIQRAY plus fulvestrant versus placebo plus fulvestrant in 572 patients with HR-positive, HER2-negative, advanced or metastatic breast cancer whose disease had progressed or recurred on or after an aromatase inhibitor-based treatment (with or without CDK4/6 combination). There were 341 patients enrolled by tumor tissue in the cohort with a PIK3CA mutation. Patients received either PIQRAY (300 mg) or placebo orally once daily on a continuous basis, plus fulvestrant (500 mg) administered intramuscularly on Cycle 1, Days 1 and 15, and then on Day 1 of every 28-day cycle. In the cohort of patients with PIK3CA-mutated cancer, progression-free survival at a median follow-up of 20 months was 11.0 months(95% confidence interval [CI], 7.5 to 14.5) in the alpelisib + fulvestrant group, as compared with 5.7 months (95% CI, 3.7 to 7.4) in the placebo + fulvestrant group (hazard ratio for progression or death, 0.65; 95% CI, 0.50 to 0.85; P<0.001)
