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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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