<p>Itovebi is a medicine used in combination with two other medicines (palbociclib and fulvestrant) to treat breast cancer when the cancer cells are ER positive and HER2-negative and have a mutation in a gene called <em>PIK3CA</em>. ER-positive means that cancer cells have receptors for oestrogen hormones on their surface and HER2-negative means that they do not have large quantities of a receptor called HER2.</p><p>Itovebi is used for cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body) when the cancer has come back during or within 12 months of adjuvant hormonal treatment. An adjuvant treatment is an additional treatment given after the main treatment to lower the risk of cancer coming back.</p><p>Patients previously given a type of cancer medicine called CDK 4/6 inhibitor can be given Itovebi, in combination with palbociclib and fulvestrant, only if the cancer has come back after at least 12 months since stopping treatment with the CDK 4/6 inhibitor.</p><p>Women who have not yet reached the menopause (pre-menopausal or perimenopausal) and men should also be given a luteinising hormone-releasing hormone (LHRH) agonist (a medicine that lowers blood levels of the hormones oestrogen and progesterone).</p><p>Itovebi contains the active substance inavolisib.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with <em>PIK3CA</em>-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). <br><br>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.</p><p>In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.</p></div>
Therapeutic Area (MeSH)
ATC Code
N/A
ATC Item
N/A
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| inavolisib | N/A | inavolisib |
EMA Name
Itovebi
Medicine Name
Itovebi
Aliases
N/ANo risk management plan link.