Novartis’ Piqray (alpelisib) + Fulvestrant Receive FDA’s Approval for Patients with a PIK3CA Mutation in HR+/HER2- Advanced/Metastatic Breast Cancer

Novartis’ Piqray (alpelisib) + Fulvestrant Receive FDA’s Approval for Patients with a PIK3CA Mutation in HR+/HER2- Advanced/Metastatic Breast Cancer

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

Click here to read full press release/ article | Ref: Novartis | Image: Anj