Tags : (alpelisib)

Novartis’ Piqray (alpelisib) + Fulvestrant Receive FDA’s Approval for Patients

Shots: The approval is based on P-III SOLAR-1 study result assessing Piqray (alpelisib) + Fulvestrant vs Fulvestrant in 572 postmenopausal women/men in ratio (1:1) with PIK3CA-mutated HR+/HER2- advanced/m-breast cancer, following aromatase inhibitor prior treated with/without CDK4/6 inhibitor The P-III SOLAR-1 study result: mPFS (11.0 mos. vs 5.7mos.); ORR (35.7% vs 16.2%). Piqray & its associated […]Read More

Novartis Reports Results of BYL719 (alpelisib) + fulvestrant in P-III

 Shots: The P-III SOLAR-1 trial assessed BYL719 (300 mg, qd) + fulvestrant (500 mg) vs PBO (fulvestrant) in 572 postmenopausal women in ratio (1:1) with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer P-III SOLAR-1 trial results: mPFS (11.0 vs 6.8 mos.), additional 1L therapy mPFS (10.9 vs 3.7 mos.), PIK3CA mutation (3% vs 2%), safe […]Read More