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 companion diagnostic test from QIAGEN is approved under FDA Oncology Center of Excellence RTOR pilot program
• Piqray (alpelisib) is a PI3K inhibitor- targeting the PI3K pathway thus inhibiting the effect of PIK3CA mutations and has received FDA’s PR designation for the same indication

Ref: Novartis | Image: Anj