Swissmedic marketing authorisation number: 69792
Swissmedic marketing authorisation date: 31.01.2025
Indication: PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer
Phase: III
Summary: Randomized, double-blind, placebo-controlled study evaluating efficacy, safety and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, HR-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy.
Sponsor: F. Hoffmann-La Roche AG
Publication of the results of clinical trials
The information given above and the links to the clinical data fulfill the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Itovebi®. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic.The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.
Veeva Nr: M-CH-00005079, 03/2025