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