Novartis' Breast Cancer PI3K Drug, Scores FDA Approval For Ultra-Rare Indication

The FDA has granted accelerated approval to Novartis AG's NVS Vijoice (alpelisib) for patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

  • Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million.
  • Under the Accelerated Approval Program, continued approval may be contingent upon verification and description of clinical benefit from confirmatory evidence.
  • Read Next: Novartis Highlights Four-Year Efficacy, Safety Data On Kesimpta In Multiple Sclerosis.
  • Alpelisib is already marketed as Piqray to treat a subset of advanced or metastatic breast cancer that is HR-positive, HER2-negative, and PIK3CA-mutated. 
  • Novartis ran a real-world study dubbed EPIK-P1, reviewing the medical charts of 57 patients. It found that those treated with Vijoice saw a reduction in the size of PROS lesions and improvements in related signs and symptoms.
  • The Company giant said it would conduct two additional Phase 2 studies: EPIK-P2 to assess safety, efficacy, and pharmacokinetics, and EPIK-P3 to look into long-term safety and efficacy for patients in EPIK-P1.
  • Price Action: NVS shares are up 0.77% at $88.85 during the premarket session on the last check Wednesday.


Posted In: BriefsBiotechNewsHealth CareFDAGeneral

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