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Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Have Received Alpelisib as Part of a Compassionate Use Program (EPIK-P1)

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Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Have Received Alpelisib as Part of a Compassionate Use Program (EPIK-P1)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 14 Feb 2023

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At a glance

  • Drugs Alpelisib (Primary)
  • Indications Growth disorders; Hypertrophy; Inflammation; Lipomatosis; Scoliosis
  • Focus Therapeutic Use
  • Acronyms EPIK-P1
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 13 Sep 2022 Results(n=39) assessing Clinical benefit of alpelisib in pediatric patients with PIK3CA-related overgrowth spectrum presented at the 47th European Society for Medical Oncology Congress
    • 07 Jun 2022 Results presented at the 58th Annual Meeting of the American Society of Clinical Oncology
    • 05 Apr 2022 According to Novartis media release, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy, based on data from this trial.

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