Palbociclib Viatris is a cancer medicine used to treat breast cancer when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). Palbociclib Viatris can only be used when the cancer cells have receptors (targets) for certain hormones on their surface (HR\-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER \[human epidermal growth factor\] negative). Palbociclib Viatris is used in the following ways: * together with an aromatase inhibitor (a hormonal medicine for cancer); * together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine. In women who have not yet reached menopause, a medicine called a luteinising hormone\-releasing hormone agonist should also be given. Palbociclib Viatris contains the active substance palbociclib and is a ‘generic medicine’. This means that Palbociclib Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Palbociclib Viatris is Ibrance. For more information on generic medicines, see the question\-and\-answer document [here](https://www.ema.europa.eu/en/documents/other/questions-and-answers-generic-medicines_en.pdf).
Therapeutic Indication
Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2\)‑negative locally advanced or metastatic breast cancer. * in combination with an aromatase inhibitor; * in combination with fulvestrant in women who have received prior endocrine therapy (see section 5\.1\). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.
Therapeutic Area (MeSH)
ATC Code
L01EF01
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Palbociclib Viatris
Medicine Name
Palbociclib Viatris
Aliases
N/ANo risk management plan link.