Itovebi

Opinion

EMA has issued an opinion on this medicine

inavolisib

Overview

On 22 May 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Itovebi, intended for the treatment of adults with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative locally advanced and metastatic breast cancer.

The applicant for this medicinal product is Roche Registration GmbH.

Itovebi will be available as 3 mg and 9 mg film-coated tablets. The active substance of Itovebi is inavolisib (ATC code: not yet assigned). Inavolisib is a phosphatidylinositol 3‑kinase (PI3K) inhibitor. It inhibits the activity of downstream targets in the PI3K signalling pathway, including Akt, resulting in reduced cellular proliferation and apoptosis in PIK3CA-mutated breast cancer cell lines.

The benefits of Itovebi, in combination with palbociclib and fulvestrant, are prolonged progression-free survival and overall survival, as shown in a phase 3 randomised, double blind, placebo-controlled study in adults with PIK3CA‑mutated, HR‑positive, HER2‑negative, locally advanced or metastatic breast cancer. The most common side effects with Itovebi include hyperglycaemia, stomatitis, diarrhoea, thrombocytopenia, fatigue, anaemia, nausea, decreased appetite, rash, headache, decreased weight, vomiting and urinary tract infection.

The full indication is:

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 (see section 5.1).

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.

In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist.

Treatment with Itovebi should be initiated by physicians experienced in the use of cancer treatments.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Itovebi

AdoptedReference Number: EMA/CHMP/134194/2025

Product details

• Name of medicine:
  Itovebi
• Active substance:
  inavolisib
• International non-proprietary name (INN) or common name:
  inavolisib
• Therapeutic area (MeSH):
  Breast Neoplasms
• EMA product number:
  EMEA/H/C/006353
• Marketing authorisation applicant:
  Roche Registration GmbH
• Opinion adopted:
  22/05/2025
• Opinion status:
  Positive