Decision: Favourable

Study Title:

A phase II study to evaluate the long-term safety and efficacy of alpelisib in patients with PIK3CA-Related Overgrowth Spectrum (PROS) who previously participated in Study CBYL719F12002 (EPIK-P1)

  • NREC Code:

    21-NREC-CT-120

  • Decision:

    Favourable

  • Meeting Date:

    17/11/2021

  • Study Type:

    CT application

  • Principal Investigator:

    Professor Alan Irvine

  • PI Institution:

    Our Lady's Children's Hospital, Crumlin

  • Sponsor:

    Novartis

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