References

1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.4.2025
2. Gennari A, et al. Ann Oncol 2021; 32:1475-1495 (ESMO Metastatic Breast Cancer Living Guideline, v1.2 April 2025)
3. Lambertini et al.eClinicalMedicine. 2023 May12;59:101931.doi: 10.1016/j.eclinm.2023.101931
4. Fillbrunn M, et al. BMC Cancer 2022; 22:1002; 2. Park L, et al. ASCO 2024 (Poster 1041)
5. MT Herrera-Abreu Cancer Res, 2016; 2 KW Song et al. Cancer Discov, 2022
6. Turner NC, Im S-A, Saura C, et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast bancer. N Engl J Med. 2024;391(17):1584-1596.
7. Jhaveri KL, Im S-A, Saura C, et al. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med 2025;393:151-16
8. Itovebi: Summary of product characteristics, 06/01/2026

Product information

Itovebi▼ (inavolib): Summary of product characteristics, 06/01/2026. Latest update available at https://www.ema.europa.eu/en/medicines/human/EPAR/itovebi

Indication:Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence.

Itovebi is currently not reimbursed in Belgium.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Questions:

brussels.medinfo@roche.com

The views and opinions expressed in this video are those of the authors and do not necessarily state or reflect those of Roche.

n.v Roche s.a  M-BE-00003997 created 02/03/2026